- Bristol Myers Squibb & Co BMY announced results from the Phase 3 CheckMate-648 trial, which had two Opdivo-based treatment combinations — Opdivo (nivolumab) plus chemotherapy, and Opdivo plus Yervoy (ipilimumab) in unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).
- The data showed that both the Opdivo-based combination therapies beat out chemotherapy alone to extend the lives of ESCC patients whose tumors can’t be removed.
- Data will be presented at the 2021 American Society of Clinical Oncology Annual Meeting.
- Compared with chemo, the Opdivo-chemo combo slashed the risk of death by 26%, while the dual immuno-oncology pairing of Opdivo and Yervoy pared down the risk by 22%.
- Patients on Opdivo and chemo lived a median of 15.4 months, and those who got Opdivo plus Yervoy lived 13.7 months versus 9.1 months for the solo chemo group.
- Progression-free survival (PFS) as determined by a blinded independent review was 6.9 months for the combo compared with 4.4 months for chemo alone.
- For Opdivo plus Yervoy, however, the results were more mixed. Median OS for patients on the combo was 13.7 months compared to patients whose tumors express PD-L1. Meanwhile, the median OS was 12.8 months in the all-randomized population.
- In terms of PFS, the I/O dual regimen didn’t hit the PFS primary endpoint in PD-(L)1 expressers.
- Opdivo plus Yervoy distinguished itself on safety, with 32% of patients in that arm reporting severe/life-threatening side effects compared with 47% in the Opdivo-chemo arm and 36% in the chemo arm.
- The median duration of response was 11.8 months for Opdivo plus Yervoy, 8.4 months for Opdivo-chemo, and 5.7 months for chemotherapy alone in PD-(L)1 expressing patients, and 11.1 months, 8.2 months, and 7.1 months, respectively, in the all-randomized pool.
- On the flip side, backing up its double win on efficacy, Opdivo-chemo posted a 53% and 47% objective response rate in patients expressing PD-(L)1 and overall, respectively.
- Related content: Benzinga's Full FDA Calendar.
- Price Action: BMY shares are up 0.06% at $64.84 in the premarket session on the last check Friday.
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