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Porsche Motorsport unveils Limited CE for circuit racing: Exclusive design, best performance: the new Porsche 911 GT3 R rennsport

One of the special features of this unique collector’s item, which is limited to 77 units, is the distinctively designed body. The Porsche 911 GT3 R rennsport combines the powerful appearance of a high-performance competition car with modern design elements. At the same time, it hails back to the sports car manufacturer's motorsport history without drifting into a retro look. Elementary performance factors of the original GT3 model, such as air resistance and aerodynamic downforce remain largely untouched. As a thoroughbred racing car, the form of the 911 GT3 R rennsport continues to follow function – but it does that in an extremely emotional and attractive way. "The new Porsche 911 GT3 R rennsport offers the experience of driving a nine-eleven-based racing car in what is probably the most primal form," Thomas Laudenbach, Vice President Motorsport, emphasises. "It gives you goose bumps whenever you look at it and it combines the finest motorsport technology with a design language that is typical of Porsche. With its exceptional performance, the 911 GT3 R rennsport makes our brand’s history both tangible and audible. It is only fitting that we will be presenting it to Porsche’s large fan community at Rennsport Reunion 7 in Laguna Seca. This is an exclusive offer to our customers that really knows only one limit: the limited edition of 77 units." This extraordinary sports car was designed by Grant Larson and Thorsten Klein from the Style Porsche team. "The 911 GT3 R rennsport will take its place as the logical successor to the modern Porsche 935. While the 935 was technically based on the near-standard 911 GT2 RS Clubsport, the 911 GT3 R rennsport uses the current 911 GT3 R of the 992 generation as its basis. Beneath the extensively redesigned carbon skin is a thoroughbred racing car," Larson emphasises. The American was Director Special Projects at Style Porsche for 14 years. Together with Thorsten Klein he is responsible for the individual, one-off vehicles of Porsche Exclusive Manufaktur. Thorsten Klein adds: "We have given the limited edition model a little more width and have visually stretched the length, while at the same time it sits very low on beautifully designed wheels. This gives it perfect proportions and makes it look even more spectacular." - Distinctive design with powerful charisma and a broad rear end Generally speaking, only the bonnet and the roof were taken over from the standard GT3 R. All other body elements have been changed. Larson and his team have adopted most of the aerodynamically optimised geometry of the vehicle's nose, including its cooling air intakes and ducts. The designers have also set visual accents in the area around the side fins and flics. They are now framed by a side cowl and protected against damage caused by external impact. The radically modified shape of the air intake and outlet panels of the front wheel arches underscores the more self-confident appearance. Conventional exterior mirrors have been eliminated and replaced by a digital equivalent. A system consisting of three cameras integrated into the outer skin of the vehicle and monitors in the cockpit now perform this task. Modifications to the racing car’s rear end have a particularly distinctive character. The huge rear wing is the dominant component facing the airflow. Its design is reminiscent of that of the legendary Brumos Porsche 935/77, with which the American Peter Gregg, together with the Dutchman Toine Hezemans and the German Rolf Stommelen, took the seventh overall victory for a Porsche at the 24 Hours of Daytona in 1978. The bold interpretation at the rear end develops a visual impact that is also reflected in the downforce numbers: to ensure that the load on the horizontal elements remains within the limits defined in the standard, they have been provided with two additional vertical supports. In terms of their function, they are reminiscent of the Porsche 962 Le Mans racing car and thus bridge the gap between past and present. A light bar consisting of fine LED strips, which now incorporate illuminated letters of the Porsche lettering, characterise the overall wider rear section. One level lower, the largely open rear apron dispenses with grille covers and panelling for weight reasons. This provides a clear view of the technical components behind it and therefore also the exhaust system with its centrally positioned twin tailpipes. The particular design claim of the 911 GT3 R rennsport is also reflected in the slightly modified interior. The monitors of the two fender-mounted exterior cameras blend harmoniously into the interior on each side. Special graphics for the splash screen of the central display and the limited edition number on the instrument panel have been given the shapes of the racing car, while ambient lighting adopts the theme of the colour-adjustable main headlights for the interior. All safety features comply with the applicable FIA standards. The particularly rigid roll cage design permits the installation of the driver's seat only. As is the case with the 911 GT3 R in use worldwide, the limited "rennsport" is thus a single-seater racing car. With their striking look, the 18-inch wheel rims from BBS in their exclusive "racing" design are also an eye-catcher. They combine all the technical requirements that a competition wheel with central locking must meet, including a high design standard. Porsche Motorsport paints them in Dark Silver Metallic as standard. - New colour concept with extended customisation options In terms of its colour concept, the 911 GT3 R rennsport is breaking new ground. Porsche is offering the new collector's item ex works with a bodyshell painted in Agate Grey Metallic and bodywork in pure carbon. The racing car will be available ex works for the first time in seven colours, including Star Ruby and Signal Orange, for example. In addition, there are three exclusive paintwork designs available that make further customisation possible. Thorsten Klein, Style Porsche Project Manager for the GT3 R rennsport: "Porsche has been shaped by its rich history. This is especially true in racing. This has subsequently inspired us, of course, but by no means did we want to produce a copy or an obvious retro paint job. The three options we selected are new interpretations that are realistic and not some blatant nod to the brand’s history." The "Rennsport Reunion Design" is based on traditional motorsport colours and launches a wave across the amazing contours of the exterior body surfaces. It flows in a way that is reminiscent of the legendary Corkscrew corner combination at Laguna Seca, the venue chosen for the world premiere of the 911 GT3 R rennsport. This tribute underscores the proportions of the vehicle and its rear wing, which is further accentuated by the still visible carbon surfaces. Together with a choice of optional paint schemes, they are generally covered with a semi-gloss clear coat. With its red and white colour scheme, the "Flacht Design" features the colours traditionally used by Porsche Motorsport. It plays visually with the flared fenders in particular. The term "Flacht" is dedicated to the district within the Porsche Development Centre Weissach, where the motorsport department is located. The third option is the "Speed Icon Design". It is based on different shades of blue, which focus primarily on the pronounced width of the vehicle. - Even more powerful racing engine In principle, the 911 GT3 R rennsport is based on Porsche's current GT3 racing car. Compared with the 911 GT3 R of the 992 generation, however, the limited edition model goes beyond the strict requirements of motorsport homologation or restrictions imposed by a "Balance of Performance" (BoP). The development team supporting Dr.-Ing. Andreas Singer has converted these additional freedoms into an even more emotional circuit car with numerous technical refinements. It combines more engine power with reduced weight and a spectacular design with an awesome sound similar to that of the 911 RSR. The result is probably the hottest track tool Porsche has ever made available as a collector’s' item. The 4.2-litre six-cylinder boxer engine of the 911 GT3 R, a power unit that revs up to 9,400 rpm, benefits in particular from the removal of the restrictions imposed by the regulations: it achieves a power peak of up to 456 kW (620 PS). This corresponds to a power output of as much as 148 hp per litre of displacement – most probably a record for a naturally aspirated engine of a GT racing car. It is thus significantly more powerful than the original power unit, which can develop up to 416 kW (565 PS) in the 911 GT3 R, depending on the BoP rating. The water-cooled four-valve engine with direct petrol injection has been designed to run on E25 fuels. These include bio-ethanol fuels and so-called reFuel, in addition to regeneratively produced e-fuels, which make almost carbon-neutral operation possible. With their lower knocking tendency, they are paving the way for more advanced ignition angles and increased compression in the six combustion chambers. The pistons and camshafts developed specifically for the GT3 R rennsport engine deliver increased performance, especially when running on E25 fuels. However, the engine can also run on conventional fuels. The power transmission to the rear wheels, including the sequential six-speed constant-mesh gearbox, originates from the 911 GT3 R with only minor modifications. Gear changes are made via steering wheel paddles that control an electronic gearshift actuator. The transmission ratio of the fourth, fifth and sixth forward gears corresponds to the Daytona set-up of the GT3 racing car. In sixth gear, with an engine speed of 9,000 rpm, it gives the car a top speed that is around 20 kph higher than the shorter FIA homologated gear ratio of the GT3 R. In the unsilenced version, the racing exhaust system with centrally positioned twin tailpipes offers an authentic and extremely emotional engine sound. Two quieter versions fitted with silencers and catalytic converters are available for racing circuits with noise restrictions. The chassis is also basically identical to that of the GT3 racing car. At the front axle, a state-of-the-art double wishbone suspension layout is still used to perform wheel guidance with a multi-link suspension incorporated at the rear. The five-way adjustable racing shock absorbers from KW have a blow-off function. Porsche Motorsport delivers the 911 GT3 R rennsport with a specific basic set-up. Further adjustments to the suspension can be made using shims. Their benefit: they enable fine adjustments to be made without the need for time-consuming measurements of the suspension. Another unique selling point of the car are the racing tyres offered by Michelin exclusively for GT3 R rennsport customers. These tyres benefit from a new construction associated with a new compound tread that result in an improved warm-up and drivability compared to the Michelin Pilot Sport M S9 (S9M). In addition, the specially developed tyre design on the sidewall of the tyre blends in seamlessly with the appearance of the vehicle. The aluminium monobloc racing brake system from AP has been given brake pads with titanium backing plates. They reduce the total unsprung masses by approximately one kilogram. The new FT3.5 safety tank with a capacity of 117 litres is also a weight-saving feature, being one kilogram lighter than the previous version and in future can also be used in the 911 GT3 R for racing events. Another weight saving feature is the elimination of the air conditioning system. Ventilation for the driver is provided by the 911 GT3 R’s seat cooling concept. Overall, the developers are aiming to achieve a kerb weight of 1,240 kilograms for the 911 GT3 R rennsport. This would be equivalent to a weight-to-power ratio of 2.0 kg/PS. Porsche Motorsport is offering the limited edition 911 GT3 R rennsport ex factory at a price of 951,000 euros (1,046,000 USD), plus country-specific VAT and options. Please register on http://motorsport-community.porsche.com/GT3Rrennsport

Four-Year Outcomes from Phase 3 CheckMate -9LA Trial Show Durable, Long-Term Survival with Opdivo (nivolumab) Plus Yervoy (ipilimumab) with Two Cycles

Patients treated with dual immunotherapy-based combination demonstrate sustained clinical benefits after four years vs. chemotherapy alone, with magnitude of benefit more pronounced amongst patient subgroups with high unmet needs Late-breaking data to be presented during the 2023 American Society of Clinical Oncology Annual MeetingPRINCETON, N.J.--(BUSINESS WIRE)--$BMY #ASCO--Bristol Myers Squibb (NYSE: BMY) today announced four-year follow-up results from the Phase 3 CheckMate -9LA trial demonstrating durable, long-term survival benefits with Opdivo (nivolumab) plus Yervoy (ipilimumab) with two cycles of chemotherapy compared to four cycles of chemotherapy alone in previously untreated patients with metastatic non-small cell lung cancer (NSCLC). With a minimum follow-up of 47.9 months, the dual immunotherapy-based combination continued to enhance overall survival (OS), the trial’s primary endpoint, with 21% of patients treated with Opdivo plus Yervoy with two cycles of chemotherapy alive compared to 16% of patients treated with chemotherapy alone at four years (Hazard Ratio [HR] 0.74; 95% Confidence Interval [CI]: 0.63 to 0.87). With extended follow-up, the clinically meaningful efficacy benefit of Opdivo plus Yervoy with two cycles of chemotherapy was maintained across secondary endpoints and key subgroups of patients, with benefits more pronounced amongst high unmet need patients with tumor PD-L1 expression <1% and squamous histology: PD-L1 <1%: Among patients with tumor PD-L1 expression <1%, the OS rate was 23% for those treated with the dual immunotherapy-based combination vs. 13% for chemotherapy alone, representing a 34% reduction in the risk of death (HR 0.66; 95% CI: 0.50 to 0.86). Squamous histology: Among those with squamous histology, twice the number of patients treated with Opdivo plus Yervoy with chemotherapy were alive at four years compared to those who received chemotherapy alone (20% vs. 10%, respectively). In this group, the dual immunotherapy combination reduced the risk of death by 36% compared to chemotherapy alone (HR 0.64; 95% CI: 0.48 to 0.84). No new safety signals were observed with Opdivo plus Yervoy with two cycles of chemotherapy with extended follow-up in the CheckMate -9LA trial. These data will be featured in a late-breaking poster presentation (Abstract #LBA9023) at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting on June 4, 2023, from 5:30 - 7:00 p.m. EDT. “The durable results seen with nivolumab plus ipilimumab with chemotherapy over four years, especially in patients typically facing a poor prognosis, demonstrate the sustained benefits of combining dual immunotherapy with limited chemotherapy for patients with advanced or metastatic non-small cell lung cancer, which remains an incredibly challenging disease to treat,” said David P. Carbone, M.D., Ph.D., CheckMate -9LA investigator and Director of the Thoracic Oncology Center at The Ohio State University Comprehensive Cancer Center – James Cancer Hospital and Solove Research Institute. “The data in patients with tumor PD-L1 expression <1% and squamous histology are particularly encouraging, as they show that the combination therapy continues to reduce the risk of death by approximately one-third compared to chemotherapy alone four years following treatment in patient groups historically facing the worst outcomes.” “Cancer treatment is never a one-size-fits-all approach given that patients with thoracic cancers like non-small cell lung cancer have diverse sets of needs. We are committed to researching solutions that work for more patients and can potentially help improve outcomes and fill areas of high unmet need,” said Abderrahim Oukessou, M.D., vice president, thoracic cancers development lead, Bristol Myers Squibb. “Our data in lung cancer at ASCO 2023 add to the growing body of evidence supporting the potential of our medicines to improve long-term outcomes for patients in both advanced settings and earlier stages of disease, as well as difficult-to-treat patient groups requiring personalized approaches to treatment. The CheckMate -9LA results, which demonstrate sustained efficacy benefits over four years with an Opdivo-based combination, further reinforce our promise to deliver durable options to more patients across varying stages and types of cancer.” Opdivo plus Yervoy-based combinations have shown significant improvements in OS in six Phase 3 clinical trials in five tumors to date: metastatic NSCLC, metastatic melanoma, advanced renal cell carcinoma, malignant pleural mesothelioma and esophageal squamous cell carcinoma. About CheckMate -9LA CheckMate -9LA is an open-label, global multi-center, randomized Phase 3 trial evaluating Opdivo (360 mg Q3W) plus Yervoy (1 mg/kg Q6W) combined with chemotherapy (two cycles) compared to chemotherapy alone (up to four cycles followed by optional pemetrexed maintenance therapy if eligible) as a first-line treatment in patients with metastatic non-small cell lung cancer (NSCLC) regardless of PD-L1 expression and histology. Patients in the experimental arm (n=361) were treated with immunotherapy for up to two years or until disease progression or unacceptable toxicity. Patients in the control arm (n=358) were treated with up to four cycles of chemotherapy and optional pemetrexed maintenance (if eligible) until disease progression or unacceptable toxicity. The primary endpoint of the trial was overall survival (OS) in the intent-to-treat (ITT) population. Secondary hierarchical endpoints included progression-free survival (PFS) and overall response rate (ORR), and the study also evaluated efficacy measures according to biomarkers. About Lung Cancer Lung cancer is the leading cause of cancer deaths globally. The two main types of lung cancer are non-small cell and small cell. Non-small cell lung cancer (NSCLC) is one of the most common types of lung cancer, representing up to 84% of diagnoses. Survival rates vary depending on the stage and type of the cancer when diagnosed. Bristol Myers Squibb: Creating a Better Future for People with Cancer Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine, and through innovative digital platforms, are turning data into insights that sharpen their focus. Deep scientific expertise, cutting-edge capabilities and discovery platforms enable the company to look at cancer from every angle. Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. Because as a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future. About Opdivo Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers. Opdivo’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression. In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In October 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union. About Yervoy Yervoy is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activity. Yervoy binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation, including the activation and proliferation of tumor infiltrating T-effector cells. Inhibition of CTLA-4 signaling can also reduce T-regulatory cell function, which may contribute to a general increase in T-cell responsiveness, including the anti-tumor immune response. On March 25, 2011, the U.S. Food and Drug Administration (FDA) approved Yervoy 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. Yervoy is approved for unresectable or metastatic melanoma in more than 50 countries. There is a broad, ongoing development program in place for Yervoy spanning multiple tumor types. INDICATIONS OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. OPDIVO® (nivolumab) is indicated for the adjuvant treatment of adult and pediatric patients 12 years of age or older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. OPDIVO® (nivolumab), in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC). OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. OPDIVO® (nivolumab) is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM). OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC). OPDIVO® (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). OPDIVO® (nivolumab) is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. OPDIVO® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. OPDIVO® (nivolumab) is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy. OPDIVO® (nivolumab) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. OPDIVO® (nivolumab), as a single agent, is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC. OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. OPDIVO® (nivolumab) is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. OPDIVO® (nivolumab) is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT). OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC). OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC). OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum- containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. IMPORTANT SAFETY INFORMATION Severe and Fatal Immune-Mediated Adverse Reactions Immune-mediated adverse reactions listed herein may not include all possible severe and fatal immune- mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment, they can also occur after discontinuation of OPDIVO or YERVOY. Early identification and management are essential to ensure safe use of OPDIVO and YERVOY. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and periodically during treatment with OPDIVO and before each dose of YERVOY. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). In general, if OPDIVO or YERVOY interruption or discontinuation is required, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below. Immune-Mediated Pneumonitis OPDIVO and YERVOY can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. In patients receiving OPDIVO monotherapy, immune- mediated pneumonitis occurred in 3.1% (61/1994) of patients, including Grade 4 (<0.1%), Grade 3 (0.9%), and Grade 2 (2.1%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated pneumonitis occurred in 7% (31/456) of patients, including Grade 4 (0.2%), Grade 3 (2.0%), and Grade 2 (4.4%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated pneumonitis occurred in 3.9% (26/666) of patients, including Grade 3 (1.4%) and Grade 2 (2.6%). In NSCLC patients receiving OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks, immune-mediated pneumonitis occurred in 9% (50/576) of patients, including Grade 4 (0.5%), Grade 3 (3.5%), and Grade 2 (4.0%). Four patients (0.7%) died due to pneumonitis. In Checkmate 205 and 039, pneumonitis, including interstitial lung disease, occurred in 6.0% (16/266) of patients receiving OPDIVO. Immune-mediated pneumonitis occurred in 4.9% (13/266) of patients receiving OPDIVO, including Grade 3 (n=1) and Grade 2 (n=12). Immune-Mediated Colitis OPDIVO and YERVOY can cause immune-mediated colitis, which may be fatal. A common symptom included in the definition of colitis was diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients, including Grade 3 (1.7%) and Grade 2 (1%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated colitis occurred in 25% (115/456) of patients, including Grade 4 (0.4%), Grade 3 (14%) and Grade 2 (8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated colitis occurred in 9% (60/666) of patients, including Grade 3 (4.4%) and Grade 2 (3.7%). Immune-Mediated Hepatitis and Hepatotoxicity OPDIVO and YERVOY can cause immune-mediated hepatitis. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients, including Grade 4 (0.2%), Grade 3 (1.3%), and Grade 2 (0.4%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune- mediated hepatitis occurred in 15% (70/456) of patients, including Grade 4 (2.4%), Grade 3 (11%), and Grade 2 (1.8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 7% (48/666) of patients, including Grade 4 (1.2%), Grade 3 (4.9%), and Grade 2 (0.4%). OPDIVO in combination with cabozantinib can cause hepatic toxicity with higher frequencies of Grade 3 and 4 ALT and AST elevations compared to OPDIVO alone. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. In patients receiving OPDIVO and cabozantinib, Grades 3 and 4 increased ALT or AST were seen in 11% of patients. Immune-Mediated Endocrinopathies OPDIVO and YERVOY can cause primary or secondary adrenal insufficiency, immune-mediated hypophysitis, immune-mediated thyroid disorders, and Type 1 diabetes mellitus, which can present with diabetic ketoacidosis. Withhold OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism; initiate hormone replacement as clinically indicated. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism; initiate hormone replacement or medical management as clinically indicated. Monitor patients for hyperglycemia or other signs and symptoms of diabetes; initiate treatment with insulin as clinically indicated. In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994), including Grade 3 (0.4%) and Grade 2 (0.6%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, adrenal insufficiency occurred in 8% (35/456), including Grade 4 (0.2%), Grade 3 (2.4%), and Grade 2 (4.2%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, adrenal insufficiency occurred in 7% (48/666) of patients, including Grade 4 (0.3%), Grade 3 (2.5%), and Grade 2 (4.1%). In patients receiving OPDIVO and cabozantinib, adrenal insufficiency occurred in 4.7% (15/320) of patients, including Grade 3 (2.2%) and Grade 2 (1.9%). In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients, including Grade 3 (0.2%) and Grade 2 (0.3%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, hypophysitis occurred in 9% (42/456), including Grade 3 (2.4%) and Grade 2 (6%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, hypophysitis occurred in 4.4% (29/666) of patients, including Grade 4 (0.3%), Grade 3 (2.4%), and Grade 2 (0.9%). In patients receiving OPDIVO monotherapy, thyroiditis occurred in 0. Contacts Bristol Myers Squibb Media Inquiries:media@bms.com Investors:investor.relations@bms.com Read full story here

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Epishine Welcomes New CEO, Anders Kottenauer, in a Strategic Leadership Transition

Porsche Motorsport unveils Limited CE for circuit racing: Exclusive design, best performance: the new Porsche 911 GT3 R rennsport

Metal and Monsters New Episode Features Rex Brown of Pantera, Dug Pinnick of King's X, and Legendary Filmmaker Roger Corman

Porsche Korea Presents the Global Artwork 'Dream Big' as Public Art Exhibition at Lotte World Tower World Park

Porsche Korea Officially Launches the New Cayenne, More Luxurious and More Powerful than Ever

Review

Review – All-New Range Rover Evoque (2019) D180 First Edition

Technical Overview of the 2nd Gen Xeon Scalable Processors

Review - Encounter of Eun-hee Kim and Netflix, ‘Kingdom’ opened a new horizon

Review – [Jekyll and Hyde] Return of the King! There Is No Such Word as “Disappointment” in Seung Woo Jo, Jo-Jekyll’s Dictionary

Review - Allm's Action Game 'CapsuleMon Fight', "A Game with Strategic confrontation of Capsule monsters" (mobile)

[CES 2021] LG Emphasized "Needs to Innovate Beyond Boundaries Between Fields in the New Normal Era" Through Future Talk

[CES 2021] Sony Unveiled Its Latest Initiatives Surpassing “Limits of Creativity” at CES 2021

Hyperconnect, Key to social platform success: reflecting the ‘user voice’

Hyperconnect : real-time video AI monitoring system can now auto-block live video content within 0.006 seconds

India Credit Card Market Competition, Forecasts & Opportunities, 2028F - A Shift from Debit-based to Credit-based Economy and Emergence of Co-branded

The FDA Approves IDE for ReGelTec’s Pivotal Study of HYDRAFIL® for Chronic Low Back Pain due to Degenerative Disc Disease

Puma Biotechnology Announces Presentation of Biomarker Findings from a Phase II Study of Alisertib with Paclitaxel versus Paclitaxel Alone in Metastat

Four-Year Outcomes from Phase 3 CheckMate -9LA Trial Show Durable, Long-Term Survival with Opdivo (nivolumab) Plus Yervoy (ipilimumab) with Two Cycles

Nucleai and Mayo Clinic BioPharma Diagnostics Announce Strategic Collaboration to Transform Digital Pathology for Drug Development and Clinical Practi