CheckMate-901 Trial

[Slide 1] 2024 ASCO ANNUAL MEETING Characterization of complete responders to nivolumab + gemcitabine-cisplatin versus gemcitabine-cisplatin alone and patients with lymph node only metastatic urothelial carcinoma from the CheckMate 901 trial Matthew D. Galsky,¹ Guru Sonpavde,² Thomas Powles,³ Melanie Claps,4 Mauricio Burotto,⁵ Michael Schenker,6 Juan Pablo Sade,⁷ Aristotelis Bamias,⁸ Philippe Beuzeboc,⁹ Jens Bedke, 10* Jan Oldenburg, 11 Yüksel Ürün, 12 Dingwei Ye, 13 Begona P. Valderrama, 14 Yoshihiko Tomita, 15 Jeiry Filian, 16 Lily Wang, 16 Daniela Purcea, 17 Michiel S. van der Heijden¹⁸ Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY; Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA; Barts Cancer Institute, Queen Mary University of London, London, UK; Fondazione IRCCS istituto Nazionale dei Tumori, Milan, Italy; Bradford Hill Clinical Research Center, Santiago, Chile; *Sf. Nectarie Oncology Center, and University of Medicine and Pharmacy, Craiova, Romania; Alexander Fleming Institute, Buenos Aires, Argentina; National and Kapodistrian University of Athens, ATTIKON University Hospital, Athens, Greece; Hopital Foch, Suresnes, France; "Eberhard Karls University Tübingen, Tübingen, Germany; "Akershus University Hospital (Ahus), Lorenskog, Norway; "Ankara University, Ankara, Turkey; "Fudan University Shanghai Cancer Center, Shanghai, China; Hospital Universitario Virgen del Rocio, Sevilla, Spain; "Nigata University Graduate School of Medical and Dental Sciences, Niigata, Japan; "Bristol Myers Squibb, Princeton, NJ; "Bristol Myers Squibb, Boudry, Switzerland; Netherlands Cancer Institute, Amsterdam, the Netherlands *Dr. Bedke is now with Eva Mayr-Stihl Cancer Center, Klinikum Stuttgart, Stuttgart, Germany Abstract number 4509 --- [Slide 2] CheckMate 901 Response per BICR ORR (95% CI) CR PR All randomized patients LN only patients 90 81.5% (68.6-90.7) 80 64.3% 70 57.6% (50.4-76.6) 60 (51.8-63.2) Patients (%) 43.1% 50 63.0% 21.7% (37.5-48.9) 33.9% 40 11.8% 30 20 35.9% 31.3% 30.4% 10 18.5% 0 SD 25.3% 28.3% SD 9.3% 25.0% PD 9.5% 12.8% PD 3.7% 5.4% UE 7.6% 15.8% UE 5.6% 5.4% NIVO+GC GC NIVO+GC GC (n = 304) (n = 304) (n = 54) (n = 56) CR rates for NIVO+GC-treated patients with LN only mUC were approximately twice that of GC-treated patients --- [Slide 3] CheckMate 901 OS: patients with LN only mUC per BICR 100 Median os (95% CI), months NIVO+GC 46.3 (24.0-NE) 90 GC 24.9 (21.4-29.9) 80 HR (95% CI), 0.58 (0.34-1.00) 70 Overall survival (%) 60 50 40 30 20 10 0 0 6 12 18 24 30 36 42 48 54 60 66 Months No. at risk NIVO+GC 54 49 41 35 24 18 13 6 5 2 1 0 GC 56 54 41 32 20 10 8 3 2 0 0 0 --- [Slide 4] CheckMate 901 Summary NIVO+GC generated deep responses in CheckMate 901 with a fixed duration of therapy and with up to 2 years of treatment with NIVO Exploratory characterization of patients with CR identified a group of patients enriched with LN only disease A subset of patients with LN only mUC in the NIVO+GC arm experienced an ongoing CR off all treatment at the time of last follow-up In patients with LN only mUC, NIVO+GC induced durable disease control and clinically meaningful improvements in os and PFS VS GC alone - ORR and CR rates were also higher with NIVO+GC VS GC alone These results provide additional support for NIVO plus cisplatin-based chemotherapy, which is now approved for patients with mUC in the US and Europe, and represents a standard first-line treatment option for this population Copies of this slide deck obtained through Quick Response (00) Code BY for personal - only and may not be reproduced without permission from ASCO* or the author of this slide deck,

[Slide 1] Abstract #4509, ASCO Annual Meeting 2024 Characterization of complete responders to nivolumab + gemcitabine-cisplatin VS gemcitabine-cisplatin alone and patients with lymph node-only metastatic urothelial carcinoma from the CheckMate 901 trial Matt D. Galsky, Guru P. Sonpavde, Thomas B. Powles, Melanie Claps, Mauricio Burotto, Michael Schenker, Juan Pablo Sade, Aristotelis Bamias, Philippe Beuzeboc, Jens Bedke, Jan Oldenburg, Yüksel Ürün, Ding-Wei Ye, Begoña P. Valderrama, Yoshihiko Tomita, Jeiry Filian, Lily Wang, Daniela Purcea, Michiel S. Van Der Heijden @neerajaiims --- [Slide 2] Abstract #4509, ASCO Annual Meeting 2024 Characterization of complete responders to nivolumab + gemcitabine-cisplatin vs gemcitabine-cisplatin alone and patients with lymph node-only metastatic urothelial carcinoma from the CheckMate 901 trial Presenting Author: Matt D. Galsky Tumor PD-L1 expression Combination phase Monotherapy phase (z 1% vs 1%) Liver metastases (yes vs no) NIVO 360 mg on D1 Key inclusion criteria NIVO 480 mg Q4W N 304 Gemcitabine 1000 mg/m2 on D1/D8 3 weeks (until progression, unacceptable Age 2 18 years Cisplatin 70 mg/m2 on D1 toxicity, withdrawal, or Previously untreated unresectable Q3W (up to 6 cycles)b up to 24 months or mUC involving the renal pelvis, R ureter, bladder, or urethra Cisplatin eligible Gemcitabine 1000 mg/m2 on D1/D8 Cisplatin 70 mg/m2 on D1 ECOG PS of 0-1 N = 304 Q3W (up to 6 cycles)b Median (range) study follow-up, 33.6 (7.4-62.4) months Primary endpoints: OS, PFS per BICR Key secondary endpoints: OS and PFS by PD-L1 > 1%, HRQoL Key exploratory endpoints: ORR per BICR, safety www.clinicaltrials.gov: CheckMate 901 (NCT03036098) @neerajaiims --- [Slide 3] Abstract #4509, ASCO Annual Meeting 2024 Characterization of complete responders to nivolumab + gemcitabine-cisplatin VS gemcitabine-cisplatin alone and patients with lymph node-only metastatic urothelial carcinoma from the CheckMate 901 trial Presenting Author: Matt D. Galsky Results: Of all randomized pts, 54 treated with NIVO + Gemcitabine - Cisplatin (GC) and 56 treated with GC had lymph node (LN)-only mUC. In these pts, the ORR and CR rate was 81.5% (95% CI 68.6-90.7) and 63.0% versus 64.3% (50.4-76.6%) and 33.9% for NIVO+GC and GC, respectively. Median os (95% CI) in LN-only pts was 46.3 (24.0-NE) mos with NIVO+GC VS 24.9 (21.4-29.9) with GC (HR, 0.58, 95% CI 0.34-1.00), and median PFS (95% CI) was 30.5 (9.6-NE) mos with NIVO+GC VS 8.8 (7.5-10.9) mos with GC (HR 0.38, 95% CI 0.22-0.66). Baseline Disease Characteristics for Pts with CR NIVO+GC GC (N = 66) (N = 36) PD-L1 status ≥1%, n (%) 28 (42.4) 11 (30.6) Liver metastasis, n (%) 5 (7.6) 1 (2.8) LN-only disease, n (%) 34 (51.5) 19 (52.8) Conclusion: NIVO+GC generated deep responses in CheckMate 901 with a fixed duration of chemotherapy and up to 2 years NIVO. In pts with LN-only mUC, NIVO+GC induced durable disease control and clinically meaningful improvements in OS and PFS VS GC alone. These results provide additional support for NIVO plus cisplatin-based chemo as a first-line treatment option for pts with mUC. @neerajaiims

[Slide 1] 2024 ASCO ANNUAL MEETING Characterization of complete responders to nivolumab + gemcitabine-cisplatin versus gemcitabine-cisplatin alone and patients with lymph node only metastatic urothelial carcinoma from the CheckMate 901 trial Matthew D. Galsky, 1 Guru Sonpavde,² Thomas Powles,³ Melanie Claps,4 Mauricio Burotto,⁵ Michael Schenker,6 Juan Pablo Sade,⁷ Aristotelis Bamias, 8 Philippe Beuzeboc,9 Jens Bedke, 10* Jan Oldenburg, 11 Yüksel Ürün, 12 Dingwei Ye, 13 Begoña P. Valderrama, 14 Yoshihiko Tomita,¹⁵ Jeiry Filian, 16 Lily Wang, 16 Daniela Purcea, 17 Michiel S. van der Heijden¹⁸ 'Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY; 2Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA; Barts Cancer Institute, Queen Mary University of London, London, UK; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy; Bradford Hill Clinical Research Center, Santiago, Chile; Sf. Nectarie Oncology Center, and University of Medicine and Pharmacy, Craiova, Romania; 'Alexander Fleming Institute, Buenos Aires, Argentina; National and Kapodistrian University of Athens, ATTIKON University Hospital, Athens, Greece; Hôpital Foch, Suresnes, France; 10Eberhard Karls University Tübingen, Tübingen, Germany; ¹Akershus University Hospital (Ahus), Lørenskog, Norway; 12Ankara University, Ankara, Turkey; ¹Fudan University Shanghai Cancer Center, Shanghai, China; ¹⁴Hospital Universitario Virgen del Rocio, Sevilla, Spain; 15Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan; "Bristol Myers Squibb, Princeton, NJ; 17Bristol Myers Squibb, Boudry, Switzerland; ¹⁸Netherlands Cancer Institute, Amsterdam, the Netherlands *Dr. Bedke is now with Eva Mayr-Stihl Cancer Center, Klinikum Stuttgart, Stuttgart, Germany Abstract number 4509 --- [Slide 2] CheckMate 901 Response per BICR ORR (95% CI) CR All randomized patients LN only patients PR 81.5% 90 (68.6-90.7) 80 64.3% 70 57.6% (50.4-76.6) 60 (51.8-63.2) Patients (%) 43.1% 50 63.0% 21.7% (37.5-48.9) 33.9% 40 11.8% 30 20 35.9% 31.3% 30.4% 10 18.5% 0 SD 25.3% 28.3% SD 9.3% 25.0% PD 9.5% 12.8% PD 3.7% 5.4% UE 7.6% 15.8% UE 5.6% 5.4% NIVO+GC GC NIVO+GC GC (n = 304) (n = 304) (n = 54) (n = 56) CR rates for NIVO+GC-treated patients with LN only mUC were approximately twice that of GC-treated patients --- [Slide 3] CheckMate 901 OS: patients with LN only mUC per BICR 100 Median os (95% CI), months NIVO+GC 90 46.3 (24.0-NE) GC 24.9 (21.4-29.9) 80 HR (95% CI), 0.58 (0.34-1.00) 70 Overall survival (%) 60 50 40 30 20 10 0 0 6 12 18 24 30 36 42 48 54 60 66 Months No. at risk NIVO+GC 54 49 41 35 24 18 13 6 5 2 1 0 GC 56 54 41 32 20 10 8 3 2 0 0 0 --- [Slide 4] CheckMate 901 PFS: patients with LN only mUC per BICR 100 Median PFS (95% CI), months 90 NIVO+GC 30.5 (9.6-NE) GC 8.8 (7.5-10.9) 80 HR (95% CI), 0.38 (0.22-0.66) 70 Progression-free survival (%) 60 50 40 30 20 10 0 0 6 12 18 24 30 36 42 48 54 Months No. at risk NIVO+GC 54 44 28 23 17 13 7 3 1 0 GC 56 28 7 2 0 0 0 0 0 0

[Slide 1] ASCO Sign in Characterization of complete responders to nivolumab + gemcitabine- : cisplatin vs gemcitabine-cisplatin alone and patients with lymph node-only metastatic urothelial carcinoma from the CheckMate 901 trial. Abstract Authors Matt D. Galsky i Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY Matt D. Galsky, Guru P. Sonpavde, Thomas Powles, Melanie Claps, Mauricio Burotto, Michael Schenker, Juan Pablo Sade, Aristotelis Bamias, Philippe Beuzeboc, Jens Bedke, Jan Oldenburg, Yuksel Orun, Ding-Wei Ye, Begona Pérez Valderrama, Yoshihiko Tomita, Jeiry Filian, Lily Wang, Daniela Purcea, Michiel Simon Van Der Heijden

[Slide 1] PFS: patients with LN only mUC per BICR 100 Median PFS (95% CI), months 90 NIVO+GC 30.5 (9.6-NE) GC 8.8 (7.5-10.9) 80 HR (95% CI), 0.38 (0.22-0.66) 70 60 50 40 11 11 30 20 10 0 0 6 12 18 24 30 36 42 48 54 No. at risk Months NIVO+GC 54 44 28 23 17 GC 13 56 7 28 3 7 1 2 0 0 0 0 0 0 0 --- [Slide 2] OS: patients with LN only mUC per BICR 100 Median os (95% CI), months 90 NIVO+GC 46.3 (24.0-NE) GC 24.9 (21.4-29.9) 80 HR (95% CI), 0.58 (0.34-1.00) 70 101 1 60 50 40 30 20 10 0 0 6 12 18 24 30 36 42 48 54 60 66 No. at risk Months NIVO+GC 54 49 41 35 24 18 13 6 5 2 1 0 GC 56 54 41 32 20 10 8 3 2 0 0 0