Bristol Myers Touts Opdivo Win in Esophageal Cancer, But Yervoy-Opdivo Combo Comes with Caution

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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