- First presentation of results from Phase 3 CheckMate -67T trial with subcutaneous formulation of Opdivo (nivolumab and hyaluronidase) to be shared in a late-breaking oral presentation
- Four-year data from CheckMate -9ER and unprecedented eight-year data from CheckMate -214 will confirm durable outcomes with Opdivo-based combinations for patients with advanced renal cell carcinoma
- First disclosure of clinical outcomes from Phase 1 trial with BMS-986365 (CC-94676), the company’s first androgen receptor ligand-directed degrader in solid tumors from its targeted protein degradation platform, in metastatic castration-resistant prostate cancer
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 Title |
Author |
Presentation |
Session Title |
Session |
|
Prostate Cancer |
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|
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 Rathkopf |
Poster Abstract #134 Poster Bd. #F5 |
Poster Session A: Prostate Cancer |
Thursday, January 25 |
|
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 George |
Oral Abstract #LBA360 |
Oral Abstract Session C: Renal Cell Cancer |
Saturday, January 27
|
|
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 Bourlon |
Rapid Oral Abstract #362 |
Rapid Oral Abstract Session C: Renal Cell, Adrenal, and Testicular Cancers |
Saturday, January 27 |
|
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 Tannir |
Rapid Oral Abstract #363 |
Rapid Oral Abstract Session C: Renal Cell, Adrenal, and Testicular Cancers |
Saturday, January 27 |
|
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 Motzer |
Oral Abstract #LBA358 |
Oral Abstract Session C: Renal Cell Cancer |
Saturday, January 27 |
|
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 Geynisman |
Poster Abstract #398 Poster Bd. #F22 |
Poster Session C: Renal Cell Cancer; Adrenal, Penile, and Testicular Cancers |
Saturday, January 27 |
|
Urothelial Carcinoma |
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|
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 Geynisman |
Oral Abstract #528 |
Role of Immunotherapy in Advanced Urothelial Carcinoma: Sequencing, Pairing, Rechallenging |
Friday, January 26 |
|
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-Raffle |
Poster Abstract #565 Poster Bd. #E14 |
Poster Session B: Urothelial Carcinoma |
Friday, January 26 |
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.
Source: Bristol Myers Squibb. (2024). Bristol Myers Squibb Data at ASCO GU 2024 Showcase Transformative Research in the Treatment of Genitourinary Cancers [Press release]. https://news.bms.com/news/corporate-financial/2024/Bristol-Myers-Squibb-Data-at-ASCO-GU-2024-Showcase-Transformative-Research-in-the-Treatment-of-Genitourinary-Cancers/default.aspx.