Opdivo/Yervoy combo flops again in melanoma, but Bristol Myers Squibb also has a new OK to celebrate
Bristol Myers Squibb’s Opdivo/Yervoy combo regimen has officially failed both co-primary endpoints in a trial testing it as an adjuvant therapy for melanoma.
Adding Yervoy, the CTLA4 inhibitor, to the PD-1 antibody Opdivo failed to induce a statistically significant improvement in recurrence-free survival among the all-comer population, the pharma giant reported. The news comes almost one year after Bristol Myers conceded that the pairing didn’t help patients with very low levels of PD-L1 — who would theoretically be less likely to benefit from Opdivo — any more than the Opdivo alone did.
The setback highlights the rocky path Bristol Myers has been on exploring the dual immunotherapy approach, which execs hoped could offer a chemo-free alternative in different types of cancers.
Results had been mixed. On the same day the latest CheckMate-915 readout was released, the FDA OK’d Opdivo plus Yervoy for the first-line treatment of patients with malignant pleural mesothelioma that cannot be removed by surgery — marking the first new drug for the tumor, which is usually found in the lung’s linings, in 16 years.
The only other therapy was approved in 2004, FDA oncology czar Richard Pazdur noted, and it was pemetrexed in combination with cisplatin.
Regulators based the OK on an open-label trial pitting Opdivo and Yervoy against chemotherapy. The Bristol Myers drugs helped patients live a median of 18.1 months versus 14.1 months on chemo.
Numbers weren’t available for CheckMate-915, but the company managed to find a silver lining, noting that it “reinforced the established benefit of Opdivo monotherapy as a standard of care in the adjuvant setting.”
“We designed this study to determine if dual immunotherapy has the potential to bring additional benefits to patients in this setting, understanding the high benchmark we would need to exceed with this trial,” Sabine Maier, head of oncology development, said in a statement.
Next steps include a complete evaluation of the full data, which will be presented at an upcoming conference.
She added that Bristol Myers will continue to explore the combo among high-risk melanoma patients in earlier stages of disease. CheckMate-915 focused on patients with stage IIIb/c/d or stage IV melanoma who have had their tumors completely removed by surgery.