Bristol-Myers Squibb (BMS) said today its marketed drug Opdivo® (nivolumab) failed a Phase III trial assessing its effectiveness as a monotherapy in patients with previously untreated advanced non-small-cell lung cancer (NSCLC).

BMS said Opdivo missed its primary endpoint in the Phase III CheckMate -026 trial, namely progression-free survival in treatment-naïve NSCLC patients whose tumors expressed programmed death ligand 1 (PD-L1) at ≥5%.

The company did not disclose data in announcing the failure, but did say it will complete a full evaluation of the CheckMate -026 data and work with investigators on a future presentation of the results.

“While we are disappointed CheckMate -026 did not meet its primary endpoint in this broad patient population, we remain committed to improving patient outcomes through our comprehensive development program,” BMS CEO Giovanni Caforio, M.D., said in a statement.

That development program, Dr. Caforio said, includes the ongoing Phase III CheckMate -227 study exploring the combination of Opdivo plus Yervoy for PD-L1–positive patients, and Opdivo plus Yervoy, or Opdivo plus chemotherapy in PD-L1–negative patients.

Two minutes after its announcement, BMS issued a second statement defending its clinical program for Opdivo: “Bristol-Myers Squibb is proud of all that the company has and aims to accomplish with Opdivo. We are indeed transforming cancer care, and remain committed to bringing the benefit of our medicines to the greatest number of patients across multiple cancers.”  

CheckMate -026 is a Phase III, open-label, randomized study of Opdivo as monotherapy compared with investigator’s choice chemotherapy in NSCLC patients who had no prior systemic treatment for advanced disease and tested positive for PD-L1 expression.

The trial randomized 541 patients to receive either Opdivo 3 mg/kg intravenously every 2 weeks or any of three chemotherapy options (gemcitabine with cisplatin/gemcitabine with carboplatin/paclitaxel with carboplatin) and nonsquamous patients (pemetrexed with cisplatin/pemetrexed with carboplatin) until disease progression, unacceptable toxicity, or completion of six cycles.

News of the trial failure sparked a selloff in BMS shares, with the company’s share price tumbling 18%, from $75.32 at the close of trading yesterday to $61.76 in premarket trading as of 9:19 a.m.

According to BMS, the Opdivo clinical development program has enrolled more than 18,000 patients.

Opdivo was the first programmed death-1 (PD-1) immune checkpoint inhibitor to receive regulatory approval anywhere in the world in July 2014 and now has regulatory approval in 54 countries including the U.S., the EU, and Japan.

In the U.S., Opdivo is approved in combination with BMS’ marketed cancer drug Yervoy® (ipilimumab) for unresectable or metastatic melanoma, and as a single agent for five indications related to BRAF V600 wild-type unresectable or metastatic melanoma, metastatic NSCLC with progression on or after platinum-based chemotherapy, advanced renal cell carcinoma (RCC), and classical Hodgkin lymphoma (cHL).

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