On October 12, 2023 Bristol Myers Squibb (NYSE: BMY) reported the presentation of data from over 55 Bristol Myers Squibb-sponsored, investigator-sponsored, and collaboration studies across our oncology portfolio in more than 10 tumor types at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023 to be held from October 20-24 in Madrid, Spain (Press release, Bristol-Myers Squibb, OCT 12, 2023, View Source [SID1234635881]). Data from the Phase 3 CheckMate -901 and CheckMate -77T studies have been selected for presentation in Presidential Symposium sessions.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Data to be presented support the role of Opdivo and Opdivo-based combinations in both earlier and metastatic stages of multiple cancer types, especially in patient groups with high unmet needs. Additional data will highlight the potential of repotrectinib in patients with TKI-naïve and -pretreated NTRK-positive solid tumors, including non-small cell lung cancer (NSCLC), as well as the benefit of treatment with Opdualag, the dual immunotherapy fixed-dose combination of the PD-1 inhibitor nivolumab and the LAG-3-blocking antibody relatlimab, in advanced melanoma.
"We are eager to share research during this year’s ESMO (Free ESMO Whitepaper) Congress on our immunotherapies and targeted therapies in both metastatic disease and earlier stages of several tumor types, including bladder cancer, melanoma and lung cancer," said Samit Hirawat, M.D., executive vice president, chief medical officer, Global Drug Development, Bristol Myers Squibb. "These new data highlight our leading development program for Opdivo and Opdivo-based combinations in earlier stages of cancer, as well as our commitment to meeting the challenging treatment needs of cancer patients by both continuing to study the potential of our existing medicines as well as advancing new assets that may target cancer’s vulnerabilities more precisely."
Key data highlighting approved or investigational therapies from Bristol Myers Squibb at ESMO (Free ESMO Whitepaper) 2023 include:
First presentation of overall survival (OS) and progression-free survival (PFS) data from the Phase 3 CheckMate -901 trial of Opdivo in combination with cisplatin-based chemotherapy followed by Opdivo monotherapy in the first-line treatment of patients with unresectable or metastatic urothelial carcinoma demonstrating survival benefits over standard-of-care cisplatin-based chemotherapy. CheckMate -901 is the first Phase 3 trial with an immunotherapy-based combination to demonstrate a survival benefit compared to standard-of-care cisplatin-based chemotherapy in the first-line treatment of this patient population. These data will be presented at the Presidential Symposium on Sunday, October 22.
First presentation of data from the Phase 3 CheckMate -77T trial of the perioperative regimen of neoadjuvant Opdivo with chemotherapy followed by surgery and adjuvant Opdivo in patients with resectable stage IIA to IIIB NSCLC. CheckMate -77T is the second positive Phase 3 trial of an Opdivo-based combination for the treatment of non-metastatic NSCLC. These data will be presented at the Presidential Symposium on Saturday, October 21.
Late-breaking results from the Phase 3 CheckMate -816 study of neoadjuvant Opdivo with chemotherapy showing improved clinical benefit according to PD-L1 expression status in patients with resectable NSCLC. Additional CheckMate -816 results will also be presented showing efficacy benefits with Opdivo plus Yervoy in resectable NSCLC.
Updated results from the registrational TRIDENT-1 trial demonstrating clinical benefit with repotrectinib in patients with NTRK-positive advanced solid tumors, including NSCLC, who often develop resistance to existing therapies.
Seven-year efficacy results from the Phase 3 CheckMate -238 trial of adjuvant Opdivo in resected stage III/IV melanoma pointing to sustained benefits and reinforcing BMS’ leadership in earlier stages of melanoma.
Subgroup data from the Phase 2/3 RELATIVITY-047 trial showing consistent benefit across subgroups with the company’s third distinct checkpoint inhibitor Opdualag (nivolumab and relatlimab-rmbw) in the first-line treatment of patients with advanced melanoma.
Summary of Select Presentations:
Abstract Title
Author
Presentation
Type/#
Session Title
Session/Poster Discussion
Date/Time@
Adrenocortical Carcinoma
EO2401 (E) peptide immunotherapy + nivolumab (N) in adrenocortical carcinoma (ACC) and metastatic pheochromocytoma/paraganglioma (MPP); EOADR1-19/SPENCER
Eric Baudin
Proffered Paper
Abstract #724O
Proffered paper session – NETs and endocrine tumors
Sunday, October 22
08:30 – 10:00 CEST / 2:30 – 4:00 AM EDT
Gastrointestinal
Factors associated with uptake of adjuvant nivolumab in a nationwide esophageal cancer patient cohort
Robert Verhoeven
Poster
Abstract #1575P
Oesophagogastric cancer
Monday, October 23
Onsite poster display
Genitourinary
Nivolumab plus gemcitabine-cisplatin vs gemcitabine-cisplatin alone for previously untreated unresectable or metastatic urothelial carcinoma: results for cisplatin-eligible patients in the phase 3 CheckMate 901 trial
Michiel van der Heijden
Proffered Paper
Abstract
#LBA7
Presidential 2
Sunday, October 22
16:30 – 18:15 CEST / 10:30 AM – 12:15 PM EDT
Clinical management and outcomes of patients with advanced renal cell carcinoma (aRCC) treated with nivolumab+ipilimumab (N+I): a real-world study
Tom Geldart
Poster
Abstract #1896P
Renal cancer
Monday, October 23
Onsite poster display
Treatment patterns among novel hormonal therapy-experienced patients with metastatic castration-resistant prostate cancer
Vivek Narayan
Poster
Abstract #1824P
Prostate cancer
Sunday, October 22
Onsite poster display
STELLAR-304: A randomized phase 3 study of zanzalintinib (XL092) and nivolumab in non-clear cell renal cell carcinoma (nccRCC)
Sumanta Pal
Poster
Abstract #1912TiP
Renal cancer
Monday, October 23
Onsite poster display
Glioblastoma
Trotabresib (CC-90010) combined with concomitant temozolomide (TMZ) plus radiotherapy (RT) and adjuvant TMZ in patients (pts) with newly diagnosed primary glioblastoma (ndGBM): updated results from a phase 1b/2 study
Maria Vieito Villar
Proffered Paper
Abstract #500O
Proffered paper session – CNS tumors
Friday, October 20
16:00 – 17:30 CEST / 10:00-11:30 AM EDT
Gynecological
Antitumor activity of farletuzumab ecteribulin in a panel of endometrial cancer patient-derived xenografts with four different molecular subtypes
Kosei Hasegawa
Poster
Abstract #786P
Gynecological cancers
Sunday, October 22
Onsite poster display
A randomized, double-blind trial of nivolumab (NIVO) vs placebo (PBO) with neoadjuvant chemotherapy (NACT) followed by adjuvant endocrine therapy (ET) ± NIVO in patients (pts) with high-risk, ER+ HER2− primary breast cancer (BC)
Sherene Loi
Proffered Paper
Abstract #LBA20
Proffered paper session – Breast cancer, early stage
Friday, October 20
14:00 – 15:40 CEST / 8:00 – 9:40 AM EDT
Head and Neck
Nivolumab (nivo) in recurrent and/or metastatic squamous cell carcinoma of head and neck (R/M SCCHN): real-world effectiveness, quality of life (QoL) of patients and their caregivers in France (ProNiHN study)
Christophe Le Tourneau
Poster
Abstract #938P
Head and neck cancers, excl. thyroid
Sunday, October 22
Onsite poster display
Patients (pts) with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) treated with nivolumab (NIVO) in the first-line (1L) or later-line (2L+) settings in Germany: Updated results from the real-world HANNA study
Boris Kubuschok
Poster
Abstract #927P
Head and neck cancers, excl. thyroid
Sunday, October 22
Onsite poster display
Thoracic
CheckMate 77T: Phase 3 study comparing neoadjuvant nivolumab (NIVO) plus chemotherapy (chemo) vs neoadjuvant placebo plus chemo followed by surgery and adjuvant NIVO or placebo for previously untreated, resectable stage II–IIIB NSCLC
Tina Cascone
Proffered Paper
Abstract
#LBA1
Presidential 1
Saturday, October 21
16:30 – 18:15 CEST / 10:30 AM – 12:15 PM EDT
Neoadjuvant nivolumab (N) + ipilimumab (I) vs chemotherapy in the phase 3 CheckMate 816 trial
Mark Awad
Proffered Paper
Abstract #1261O
Proffered paper session – non-metastatic NSCLC and other thoracic malignancies
Friday, October 20
14:00 – 15:45 CEST / 8:00 – 9:45 AM EDT
Neoadjuvant nivolumab (N) + chemotherapy (C) in the phase 3 CheckMate 816 study: 3-y results by tumor PD-L1 expression
Mariano Provencio Pulla
Mini Oral
Abstract #LBA57
Mini oral session 2 – non-metastatic NSCLC and other thoracic malignancies
Monday, October 23
14:45 – 15:55 CEST / 8:45 – 9:55 AM EDT
Repotrectinib in patients (pts) with NTRK fusion-positive (NTRK+) advanced solid tumors, including NSCLC: Update from the phase 1/2 TRIDENT-1 trial
Ben Solomon
Poster
Abstract #1372P
NSCLC, metastatic
Monday, October 23
Onsite poster display
Nivolumab (nivo) resumption in patients with advanced or metastatic non-small cell lung cancer (aNSCLC): Survival outcomes based on France and Germany real-world data (RWD)
Maurice Pérol
Poster
Abstract #1455P
NSCLC, metastatic
Monday, October 23
Onsite poster display
First-line nivolumab (NIVO) plus ipilimumab (IPI) with two cycles of chemotherapy in patients with metastatic non-small cell lung cancer (NSCLC): Results from an interim analysis of the non-interventional FINN study
Jonas Kuon
Poster
Abstract #1448P
NSCLC, metastatic
Monday, October 23
Onsite poster display
SAPPHIRE: Phase 3 Study of sitravatinib Plus nivolumab Versus Docetaxel in Patients with Previously Treated Advanced Non-Squamous Non-Small Cell Lung Cancer
Hossein Borghaei
Proffered Paper
Abstract #LBA63
Proffered paper session – NSCLC, metastatic
Friday, October 20
16:00 – 17:30 CEST / 10:00 – 11:30 AM EDT
Melanoma
Adjuvant nivolumab (NIVO) vs ipilimumab (IPI) in resected stage III/IV melanoma: 7-y results from CheckMate 238
Paolo Ascierto
Poster
Abstract #1089P
Melanoma and other skin tumors
Sunday, October 22
Onsite poster display
Nivolumab (NIVO) plus relatlimab (RELA) vs NIVO in previously untreated metastatic or unresectable melanoma: 2-year subgroup analyses from RELATIVITY-047
Georgina Long
Poster
Abstract #1103P
Melanoma and other skin tumors
Sunday, October 22
Onsite poster display
Comparison of intracranial (IC) response assessment criteria in patients (pts) with melanoma brain metastases (MBM) treated with combination nivolumab (NIVO) plus ipilimumab (IPI) in CheckMate 204
Raymond Huang
Poster
Abstract #1135P
Melanoma and other skin tumors
Sunday, October 22
Onsite poster display
Unraveling relatlimab (RELA)-specific biology using biomarker analyses in patients with advanced melanoma treated with nivolumab (NIVO)+RELA or NIVO alone in RELATIVITY-047
Evan Lipson
Mini Oral
Abstract #LBA51
Mini oral session – Melanoma and other skin tumors
Saturday, October 21
14:45 – 16:10 CEST / 8:45 – 10:10 AM EDT
Evaluation of surrogate endpoints for overall survival within the RELATIVITY-047 trial
Peter Mohr
Poster
Abstract #1102P
Melanoma and other skin tumors
Sunday, October 22
Onsite poster display
Cross-Tumor/Solid Tumor
Recommended phase 2 dose (RP2D) selection and pharmacodynamic (PD) data of the first-in-human immune-stimulating antibody conjugate (ISAC) BDC-1001 in patients (pts) with advanced HER2-expressing solid tumors
Bob Li
Mini Oral
Abstract #657MO
Mini oral session – Developmental therapeutics
Monday, October 23
16:30 – 18:00 CEST / 10:30 AM – 12:00 PM EDT
Clinical benefit of immunotherapies in advanced cancer in France: a population-based estimate from 2014 to 2021
Isabelle Borget
Poster
Abstract #1752P
Policy and preventive strategies
Sunday, October 22
Onsite poster display
Early Assets
GUIDE.MRD: A Consortium Guiding Multi-Modal Therapies Against Minimal Residual Disease (MRD) by Liquid Biopsy to Assess Implementation of circulating tumor DNA (ctDNA) in Clinical Practice to Improve Patient Outcomes
Klaus Pantel
Poster
Abstract #237TiP
Biomarkers (agnostic)
Saturday, October 21
Onsite poster display
All abstracts except late-breaking abstracts will be available on the ESMO (Free ESMO Whitepaper) website at 00:05 CEST Monday, October 16 (6:05 PM EDT on Sunday, October 15). All late-breaking abstracts will be available on the ESMO (Free ESMO Whitepaper) website at 00:05 CEST on Thursday, October 19 (6:05 PM EDT on Wednesday, October 18).