BMS shares fall on mixed cancer immunotherapy results

Bristol-Myers Squibb’s shares have fallen sharply in pre-opening trading after mixed results from its cancer immunotherapy Opdivo in lung cancer.

BMS is playing catch-up with Merck & Co’s immunotherapy Keytruda (pembrolizumab), which is now established as standard of care in the highly lucrative first-line lung cancer indication.

Opdivo (nivolumab) has yet to produce convincing results in first line lung cancer and BMS had been hoping that combining it with chemotherapy would produce results in patients regardless of whether their tumours express PD-L1 biomarkers.

Results from “Part 1a” of the CheckMate-227 study met one of its primary goals, with low-dose of BMS’ other immunotherapy Yervoy and Opdivo showing superiority to chemotherapy in patients whose tumours expressed more than trace levels of the biomarker PD-L1.

BMS noted that this was the first time a dual immunotherapy combination had achieved an overall survival benefit compared with chemotherapy.

However it remains to be seen whether patients and doctors will favour a burdensome regime including two immunotherapies when they may have the option to take a single immunotherapy.

Those with higher levels of PD-L1 may opt to take Keytruda monotherapy, without the side effects associated with Yervoy.

But in part 2 of the trial Opdivo plus chemotherapy failed to outperform a chemotherapy arm in patients with first-line non-squamous non-small cell lung cancer when measured against an overall survival benchmark.

The median OS for patients treated with Opdivo plus chemotherapy was 18.83 months vs. 15.57 months for chemotherapy, and the one-year OS was 67.3 percent vs. 59.2 percent, respectively.

In an exploratory analysis of patients with first-line squamous NSCLC, the median OS was 18.27 months for Opdivo plus chemotherapy vs. 11.96 months for chemotherapy.

Fouad Namouni, head of oncology development at BMS, said: “While this is not the outcome we had hoped for, the Opdivo plus chemotherapy one-year landmark overall survival in the non-squamous population was consistent with the experimental arms in previously-reported trials of IO/chemotherapy combination regimens.”

“We thank the patients and investigators who participated in this trial.”