Clovis Oncology initiates combo clinical trial with rociletinib, Genentech drug

BOULDER – Clovis Oncology Inc. (Nasdaq: CLVS) on Wednesday announced that it has begun a clinical trial looking at the use of drug candidate rociletinib in combination with Genentech’s drug atezolizumab to treat lung cancer.

Clovis is sponsoring the Phase 1b/2 trial, though specific terms of the deal were not announced. The first portion of the trial will be used to assess the safety and activity of the drug combination, while the second portion will evaluate activity of the drug in two subgroups of patients with EGFR-mutant advanced or metastatic non-small cell lung cancer.

The first patient is expected to be enrolled in the coming weeks at the University of California Los Angeles, though patients will be enrolled in the study throughout the United States and Europe, company officials said.

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Clovis is aiming for 2016 to be a big year for rociletinib, which is in a series of trials looking at its use in the treatment of non-small cell lung cancer. The path to regulatory approval, however, hasn’t come without some bumps, including delays, a sagging stock price and lawsuits from shareholders.

Clovis last summer filed a New Drug Application with the U.S. Food and Drug Administration for rociletinib’s use in treating lung cancer, with a decision originally slated for March 30. But the company announced in November that the FDA had requested more data on rociletinib in part because the number of study patients with unconfirmed responses to the drug who had converted to confirmed responses was lower than had been expected.

That caused the FDA to extend the goal date for a decision on the drug to June 28, and led to a major selloff of Clovis stock that saw the company’s share price crash from nearly $100 to less than $26 in just more than a week’s time.

Clovis shares were trading at $21.22 just before Wednesday’s closing bell, down more than 5 percent from Tuesday’s close.