On September 9, 2024 Bristol Myers Squibb (NYSE: BMY) reported the presentation of nearly 60 abstracts of company-sponsored studies, investigator-sponsored studies, and collaborations from across its oncology portfolio and pipeline at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 to be held from September 13-17 in Barcelona, Spain (Press release, Bristol-Myers Squibb, SEP 9, 2024, View Source [SID1234646425]).
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"Our data at ESMO (Free ESMO Whitepaper) this year highlight BMS’ enduring impact in oncology and offer insights into our earlier-phase, next-generation assets," said Samit Hirawat, M.D. , executive vice president, chief medical officer and head of development, Bristol Myers Squibb. "We are proud to continue to expand our oncology leadership and showcase progress within our diversified pipeline, including novel ADCs and protein degraders, to advance the next wave of breakthrough cancer treatments and offer more options for patients across a wide range of tumor types."
Key data being presented by Bristol Myers Squibb at ESMO (Free ESMO Whitepaper) Congress 2024 include:
Data supporting our innovative oncology portfolio
Ten-year follow-up data from the Phase 3 CheckMate –067 trial showed the continued durable, long-term survival benefit of Opdivo (nivolumab) plus Yervoy (ipilimumab) in patients with advanced or metastatic melanoma. These data represent the longest reported median overall survival from a Phase 3 advanced melanoma trial. (LBA43)
An update of clinical outcomes from the Phase 3 CheckMate -77T trial evaluating an Opdivo -based perioperative regimen in patients with resectable non-small cell lung cancer (NSCLC) (LBA50)
Expanded analyses from the CheckMate -9DW trial evaluating Opdivo plus Yervoy vs lenvatinib or sorafenib as first-line (1L) treatment for unresectable hepatocellular carcinoma (uHCC) (965MO)
Subgroup efficacy and expanded safety data from the Phase 3 CheckMate –8HW trial evaluating Opdivo plus Yervoy as first-line treatment for microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC) (541P)
Updated efficacy and safety results at approximately 15-months of follow up from the Phase 3 CheckMate –67T trial evaluating subcutaneous nivolumab in patients with previously treated advanced or metastatic clear cell renal cell carcinoma (1691P)
Efficacy and safety data from the randomized Phase 3 KRYSTAL-12 trial evaluating KRAZATI (adagrasib) versus docetaxel in patients with pretreated locally advanced or metastatic NSCLC harboring a KRAS G12C mutation and baseline brain metastases (LBA57)
Studies supporting our advancing pipeline
Data from the proof-of-concept, randomized, Phase 2 RELATIVITY-104 trial evaluating the combination of nivolumab and relatlimab (1:1) plus platinum-doublet chemotherapy (PDCT) as first-line treatment for stage IV or recurrent NSCLC (LBA53)
BMS is initiating the Phase 3 RELATIVITY-1093 trial evaluating the fixed-dose combination of nivolumab and relatlimab (FDC 1:1) plus chemotherapy versus pembrolizumab plus chemotherapy as a first-line treatment for patients with stage IV or recurrent non-squamous NSCLC with tumor cell PD-L1 expression of 1 to 49%, supported by findings from the RELATIVITY-104 trial
First data from the randomized, Phase 2 CA001-050 trial evaluating BMS-986012, an anti-fucosyl-GM1 monoclonal antibody, in combination with carboplatin, etoposide, and nivolumab as a first-line therapy in newly diagnosed patients with extensive-stage small cell lung cancer: interim analysis (1786O)
Updated safety and clinical activity from first-in-human Phase 1 trial evaluating the targeted protein degrader BMS-986365, the company’s potential best-in-class oral dual androgen receptor ligand-directed degrader (AR LDD) and antagonist, in heavily pre-treated patients with metastatic castration-resistant prostate cancer (1597MO)
Three presentations of data evaluating BL-B01D1, a bispecific antibody-drug conjugate (ADC) targeting both EGFR and HER3 being developed in collaboration with SystImmune, Inc., in locally advanced or metastatic biliary tract cancer, locally advanced or metastatic urothelial carcinoma, and locally advanced or metastatic esophageal squamous cell carcinoma (54P, 1959O and 1426P)
Bristol Myers Squibb will host an investor webcast on Saturday, September 14 at 20:00 CEST (2:00 p.m. EDT) to discuss advancements in our cancer pipeline, including key data at ESMO (Free ESMO Whitepaper). Company executives will provide an overview at the meeting and address inquiries from investors and analysts.
Investors and the general public are invited to listen to a live webcast at View Source and are urged to register prior to the webcast.
Those unable to register can access the live conference call by dialing in the U.S. toll-free +1 833-816-1116 or international +1 412-317-0705. Materials related to the call will be available at View Source prior to the start of the conference call.
Please see below for Important Safety Information and full Prescribing Information for Opdualag (nivolumab and relatlimab-rmbw), Opdivo plus Yervoy, and KRAZATI .
Summary of Presentations:
Select Bristol Myers Squibb studies at the ESMO (Free ESMO Whitepaper) Congress 2024 include:
Abstract Title
Author
Presentation Type/#
Session Title
Session Date/Time
Gastrointestinal Cancers
Nivolumab (NIVO) plus ipilimumab (IPI) vs lenvatinib (LEN) or sorafenib (SOR) as first-line (1L) treatment for unresectable hepatocellular carcinoma (uHCC): expanded analyses from CheckMate 9DW
Thomas Decaens
Mini oral
965MO
GI tumors, upper
Monday, September 16
08:30 – 10:00 CEST / 2:30 – 4:00 AM EDT
Nivolumab (NIVO) plus ipilimumab (IPI) vs chemotherapy (chemo) as first-line (1L) treatment for microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC): subgroup efficacy and expanded safety analyses from CheckMate 8HW
Thierry Andre
Poster
541P
Colorectal cancer
Monday, September 16
Onsite poster display
BL-B01D1, an EGFR x HER3 Bispecific Antibody-drug Conjugate (ADC), in Patients with Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)
Liu Chang
Poster
1426P
Oesophagogastric cancer
Monday, September 16
Onsite poster display
BL-B01D1, an EGFR x HER3 Bispecific Antibody-drug Conjugate (ADC), in Patients with Locally Advanced or Metastatic Biliary Tract Carcinoma (BTC)
Zhihao Lu
Poster
54P
Biliary tract cancer, incl. cholangiocarcinoma
Monday, September 16
Onsite poster display
Real-World Data on the Use of Nivolumab plus Chemotherapy for Patients with Metastatic GC/GEJC/EAC: A Canadian Perspective
Mustapha Tehfe
Poster
1415P
Oesophagogastric cancer
Monday, September 16
Onsite poster display
Long-term management and outcomes in gastroesophageal cancer in Norway
Aleksander Kolstad
Poster
1459P
Oesophagogastric cancer
Monday, September 16
Onsite poster display
Genitourinary Cancers
BL-B01D1, an EGFR x HER3 Bispecific Antibody-drug Conjugate (ADC), in Patients with Locally Advanced or Metastatic Urothelial Carcinoma (mUC)
Dingwei Ye
Oral
1959O
GU tumors, non-prostate
Friday, September 13
14:00-15:30 PM CEST / 8:00 – 9:30 AM EDT
Subcutaneous nivolumab (NIVO SC) vs intravenous nivolumab (NIVO IV) in patients (pts) with previously treated advanced or metastatic clear cell renal cell carcinoma (ccRCC): updated efficacy and safety results from CheckMate 67T
Laurence Albiges
Poster
1691P
Renal cancer
Sunday, September 15
Onsite poster display
Clinical activity of BMS-986365 (CC-94676), a dual androgen receptor (AR) ligand-directed degrader and antagonist, in heavily pretreated patients (pts) with metastatic castration-resistant prostate cancer
Dana Rathkopf
Oral
1597MO
GU tumors, prostate
Monday, September 16
10:15 – 11:45 CEST / 4:15 – 5:45 AM EDT
Real-world (RW) characteristics and outcomes in patients (pts) with muscle-invasive urothelial carcinoma (MIUC) treated with adjuvant nivolumab (NIVO) with or without neoadjuvant chemotherapy (NAC)
Ebrahimi Hedyeh
Poster
1992P
Urothelial cancer
Sunday, September 15
Onsite poster display
Novel serum glycoproteomic biomarkers predict response to nivolumab plus cabozantinib (NIVO+CABO) versus sunitinib (SUN) in advanced RCC (aRCC): analysis from CheckMate 9ER
David A. Braun
Mini oral
1694MO
GU tumors, non-prostate
Sunday, September 15
08:30-10:00 CEST / 2:30-4:00 AM EDT
Health-related quality of life from the CheckMate 901 trial of nivolumab as first-line therapy for unresectable or metastatic urothelial carcinoma
Jens Bedke
Oral
1960O
GU tumors, non-prostate
Monday, September 16
08:30-10:00 AM CEST / 2:30 – 4:00 AM EDT
Melanoma
Ten-year survival outcomes of the CheckMate 067 phase 3 trial of nivolumab plus ipilimumab in advanced melanoma
James Larkin
Mini Oral
LBA43
Melanoma and other skin tumors
Sunday, September 15
14:45 – 16:15 CEST / 8:45 – 10:15 AM EDT
Nivolumab plus relatlimab vs nivolumab in previously untreated metastatic or unresectable melanoma: 3-year subgroup analyses from RELATIVITY-047
Dirk Schadendorf
Poster
1092P
Melanoma and other skin tumors
Saturday, September 14
Onsite poster display
Adjuvant nivolumab v placebo in stage IIB/C melanoma: 3-year results from CheckMate 76K
Georgina Long
Mini Oral
1077MO
Melanoma and other skin tumors
Sunday, September 15
14:45 – 16:15 CEST / 8:45 – 10:15 AM EDT
Thoracic Cancers
Nivolumab (NIVO) plus relatlimab with platinum-doublet chemotherapy (PDCT) vs NIVO + PDCT as first-line (1L) treatment (tx) for stage IV or recurrent NSCLC: results from the randomized phase 2 RELATIVITY-104 study
Nicolas Girard
Oral
LBA53
NSCLC, metastatic
Saturday, September 14
08:30 – 10:00 CEST / 2:30 – 4:00 AM EDT
Perioperative nivolumab (NIVO) vs placebo (PBO) in patients (pts) with resectable NSCLC: clinical update from the phase 3 CheckMate 77T study
Mariano Provencio
Mini-oral
LBA50
Non-metastatic NSCLC
Sunday, September 15
10:15 – 11:30 CEST / 4:15 – 5:30 AM EDT
Adagrasib versus docetaxel in patients with KRAS G12C-mutated locally advanced or metastatic NSCLC and baseline brain metastases: results from KRYSTAL-12
Fabrice Barlesi
Mini-oral
LBA57
NSCLC metastatic
Saturday, September 14
10:15 – 11:45 CEST / 4:15 – 5:45 AM EDT
BMS-986012 (anti-fucosyl-monosialoganglioside-1 [Fuc-GM1]) with carboplatin + etoposide (CE) + nivolumab (N) as first-line therapy in extensive-stage small cell lung cancer (ES-SCLC): interim analysis (IA) of a randomized phase 2 study
Ewa Kalinka
Oral
1786O
Non-metastatic NSCLC
Friday, September 13
14:00 – 15:30 CEST / 8:00 – 9:30 AM EDT
Association between early endpoints and survival outcomes in neoadjuvant treatment of resectable non-small cell lung cancer (NSCLC): A multi-country retrospective study
Mariano Provencio Pulla
Poster
1230P
NSCLC, early stage
Saturday, September 14
Onsite poster display
Real-world immunotherapy (IO) rechallenge outcomes with nivolumab (NIVO) in advanced non-small cell lung cancer (aNSCLC) in France: LIST study interim results
Benoit Bodbert
Poster
1317P
NSCLC, metastatic
Saturday, September 14
Onsite poster display
Expression Analysis of Fuc-GM1 Ganglioside in First-Line Therapy for Extensive-Stage Small Cell Lung Cancer (ES-SCLC) with BMS-986012, Nivolumab, and Carboplatin-Etoposide
Kenneth J. O’Byrne
Poster
1801P
SCLC
Saturday, September 14
Onsite poster display
KRYSTAL-7: a phase 3 study of first-line adagrasib plus pembrolizumab versus pembrolizumab alone in patients with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation
Marina C. Garassino
Poster
1394TiP
NSCLC, metastatic
Saturday, September 14
Onsite poster display
Real-world treatment and overall survival (OS) in patients (pts) with ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) in England between 2014 and 2023
Alistair Greystoke
Poster
1291P
NSCLC, metastatic
Saturday, September 14
Onsite poster display
Nivolumab (NIVO) in the first-line (1L) or second-line (2L) and later (2L+) settings in patients (pts) with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN): Updated results from the German non-interventional study (NIS), HANNA
A. Dietz
Poster
873P
Head and neck cancer, excluding thyroid
Saturday, September 14
Onsite poster display
All regular abstracts, except late-breaking abstracts, are available on the ESMO (Free ESMO Whitepaper) Congress 2024 website as of 00:05 CEST on Monday, September 9. All late-breaking abstracts will be available on the ESMO (Free ESMO Whitepaper) Congress 2024 website at 00:05 CEST on the day of presentation.