Bristol-Myers Squibb Company (BMY) European Society for Medical Oncology Congress (ESMO) 2024 summary

Strategic oncology focus and pipeline evolution

• Reinforced commitment to immuno-oncology (I-O) leadership and diversification beyond I-O, with a focus on dual I-O therapies and novel modalities.

• Presented 10-year follow-up data for dual I-O in metastatic melanoma, showing transformational patient outcomes.

• Advanced subcutaneous nivolumab filings, with U.S. PDUFA date at year-end and European review ongoing.

• Eight new registrational trials underway or planned, expanding into new solid tumor targets and indications.

• Oncology pipeline optimized by deprioritizing some programs and adding new best-in-class and first-in-class assets.

Key clinical data and trial updates

• RELATIVITY-104 Phase II trial: Nivolumab + relatimab high dose plus chemo showed doubled response rates and improved PFS in PD-L1 1-49% non-squamous NSCLC, with manageable safety.

• Efficacy in this subgroup outperformed historical benchmarks, supporting a Phase III trial versus pembro + chemo, with OS as the primary endpoint.

• Encouraging results in PD-L1 >50% non-squamous NSCLC may expand addressable population.

• Anti-fucosyl-GM1 antibody plus nivo + chemo in small cell lung cancer showed promising OS benefit and manageable safety, with Phase III to start early next year.

Expansion into novel modalities and platforms

• Protein degradation: ARLDD program in metastatic CRPC showed PSA responses and durability, with Phase III planned for 2025.

• Bispecific ADC (EGFR/HER3): Promising Phase I activity in multiple tumor types, especially metastatic bladder cancer, with global registrational trials planned for 2025.

• Radiopharmaceuticals: RayzeBio acquisition brings late-stage assets and manufacturing; RYZ101 in GEP-NET and breast cancer shows early efficacy and safety, with Phase III ongoing and new programs advancing.

• PRMT5 inhibitor: Early Phase I data show promising efficacy and safety in MTAP-deleted tumors, with further data and rapid development planned.