Bristol Myers Squibb Data at ASCO GU 2024 Showcase Transformative Research in the Treatment of Genitourinary Cancers

Bristol Myers Squibb (NYSE: BMY) today announced the presentation of data at the American Society of Clinical Oncology 2024 Genitourinary Cancers Symposium (ASCO GU) to be held from January 25-27 in San Francisco, California, highlighting the company’s progress in making long-term survival outcomes a possibility for more patients with genitourinary cancers, as well as showcasing potential new options and therapeutic platforms that may transform treatment paradigms across tumor types. Data from 14 company-sponsored studies, investigator-sponsored studies and collaborations will be presented at the meeting.

The first presentation of data from the CheckMate -67T study will highlight the potential of a subcutaneous formulation of nivolumab co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20) in advanced or metastatic clear cell renal cell carcinoma (RCC). Research to be shared will also add to the evidence supporting the use of Opdivo (nivolumab)-based combinations in patients with advanced RCC, including four-year follow-up data from the CheckMate -9ER trial and eight-year results from the CheckMate -214 trial. In addition, data will be presented on an investigational androgen receptor (AR) ligand-directed degrader (LDD; BMS-986365) in metastatic castration-resistant prostate cancer (mCRPC), providing validation for the targeted protein degradation platform in solid tumors and representing one of the company’s next waves of potential registrational assets.

“We are excited to present our research at ASCO GU 2024, which will demonstrate not only our long-standing leadership in oncology with our work in immunotherapy, but also our commitment to developing new assets and approaches to treating cancer from our differentiated research platforms such as targeted protein degradation in an effort to provide patients with better, long-term outcomes,” said Samit Hirawat, M.D., executive vice president and chief medical officer, Drug Development, Bristol Myers Squibb. “These results simultaneously showcase the ongoing success of Opdivo-based combinations in metastatic disease and our contributions to the future of cancer treatment and research. We are especially eager to share data for the first time showing the potential of our subcutaneous formulation of a proven agent, and a new mechanism of action in a difficult-to-treat tumor type – both of which could have a tremendous impact on existing standards of care and the patient experience.”

Key data being presented by Bristol Myers Squibb at ASCO GU 2024 include:

  • First disclosure of pharmacokinetics, efficacy and safety results from the Phase 3 CheckMate -67T trial with subcutaneous nivolumab (nivolumab and hyaluronidase) being presented in a late-breaking oral session. This marks the first presentation of data evaluating subcutaneous nivolumab compared to its intravenous formulation.
  • Eight-year data from the Phase 3 CheckMate -214 study with Opdivo plus Yervoy (ipilimumab) showing ongoing survival and response benefits over sunitinib among intermediate- and poor-risk patients with advanced RCC, as well as among all randomized patients. These data represent the longest survival benefit vs. sunitinib reported in patients with previously untreated advanced or metastatic RCC.
  • Four-year follow-up data from the Phase 3 CheckMate -9ER trial evaluating Opdivo in combination with Exelixis’ CABOMETYX (cabozantinib). These data demonstrate meaningful, long-term efficacy benefits seen with the combination therapy over sunitinib and reinforce it as a standard of care for previously untreated advanced RCC.
  • First presentation of clinical outcomes from the company’s targeted protein degradation platform in solid tumors with Phase 1 data from BMS-986365 (CC-94676), an oral drug selectively targeting AR. BMS-986365 induces effective and durable suppression of AR signaling, overcomes resistance to existing AR pathway inhibitors (ARPI) therapies and shows promising clinical activity in heavily pre-treated patients with mCRPC across wildtype, amplified and mutant AR status, highlighting this asset as the potential best-in-class AR-ligand directed degrader that may help overcome resistance to standard of care ARPIs in patients with mCRPC, a difficult-to-treat tumor type.

Summary of Presentations:

Abstract TitleAuthorPresentation
Session TitleSession
Date/Time (ET)
Prostate Cancer
First-in-human phase 1 study of CC-94676, a first-in-class androgen receptor (AR) ligand-directed degrader (LDD), in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC). Dana RathkopfPoster Abstract #134 Poster Bd. #F5Poster Session A: Prostate CancerThursday, January 25

2:30 PM – 4:00 PM
Renal Cell Carcinoma
Subcutaneous nivolumab (NIVO SC) vs intravenous nivolumab (NIVO IV) in patients with previously treated advanced or metastatic clear cell renal cell carcinoma (ccRCC): Pharmacokinetics (PK), efficacy, and safety results from CheckMate 67T.Saby GeorgeOral Abstract #LBA360Oral Abstract Session C: Renal Cell CancerSaturday, January 27
11:10 AM – 12:45 PM
Nivolumab plus cabozantinib (N+C) vs sunitinib (S) for previously untreated advanced renal cell carcinoma (aRCC): Results from 55-month follow-up of the CheckMate 9ER trial.Maria Teresa BourlonRapid Oral Abstract #362Rapid Oral Abstract Session C: Renal Cell, Adrenal, and Testicular CancersSaturday, January 27

4:00 PM – 5:15 PM
Nivolumab plus ipilimumab (NIVO+IPI) vs sunitinib (SUN) for first-line treatment of advanced renal cell carcinoma (aRCC): Long-term follow-up data from the phase 3 CheckMate 214 trial.Nizar TannirRapid Oral Abstract #363Rapid Oral Abstract Session C: Renal Cell, Adrenal, and Testicular CancersSaturday, January 27

4:00 PM – 5:15 PM
Adjuvant nivolumab monotherapy vs placebo for localized renal cell carcinoma at high risk of relapse after nephrectomy: Results from Part B of the randomized, phase 3 CheckMate 914 trial.Robert MotzerOral Abstract #LBA358Oral Abstract Session C: Renal Cell CancerSaturday, January 27

11:10 AM – 12:45 PM
Treatment patterns and costs among patients with metastatic renal cell carcinoma (mRCC) in the United States: A real-world study using integrated claims and clinical data.Daniel GeynismanPoster Abstract #398 Poster Bd. #F22Poster Session C: Renal Cell Cancer; Adrenal, Penile, and Testicular CancersSaturday, January 27

10:00 AM – 11:00 AM
Urothelial Carcinoma
Estimating the impact of adjuvant treatment with nivolumab on long-term survivorship rates compared with surveillance: Analyses of disease-free survival (DFS) from the phase 3 CheckMate-274 trial.Daniel GeynismanOral Abstract #528Role of Immunotherapy in Advanced Urothelial Carcinoma: Sequencing, Pairing, RechallengingFriday, January 26

5:30 PM – 6:45 PM
Characteristics of patients (pts) with muscle-invasive urothelial carcinoma (MIUC) who received adjuvant nivolumab (NIVO) or adjuvant platinum-based chemotherapy (CHEMO) in the real-world (RW) setting.Alex Chehrazi-RafflePoster Abstract #565 Poster Bd. #E14Poster Session B: Urothelial CarcinomaFriday, January 26

2:30 PM – 4:00 PM

All abstracts except late-breaking abstracts will be available on ASCO’s digital program at 5:00 PM Eastern Time (ET) on January 22, 2024. All late-breaking abstracts will be available on ASCO’s digital program at 10:00 AM ET on their day of presentation at the meeting.

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 understanding of causal human biology, cutting-edge capabilities and differentiated research platforms uniquely position the company to approach 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. As a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.

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