- Mature data shows 45 percent of patients improved on treatment
- Researchers say more data needed to clarify rociletinib's role
Researchers who led a trial of Clovis Oncology Inc.’s experimental lung cancer drug, which is likely to be rejected next month by U.S. regulators, updated results from tests of the treatment after they said initial, promising data from the clinical trial were hurried out last year.
The drug’s actual response rate in patients with a form of non-small cell lung cancer was somewhere between the promising results that were released last April and disappointing data from November, said the researchers, led by Lecia Sequist, an oncologist at Massachusetts General Hospital. The updated findings were published Wednesday in a letter to the New England Journal of Medicine.
“The desire to bring helpful therapies to patients with terminal disease quickly creates considerable pressure to disseminate promising results early,” the researchers said in the letter. “However, this case offers a clear lesson regarding the importance of continued follow-up and supports a strong recommendation to publish rates of confirmed response.”
Non-small cell lung cancer is the most common type of lung cancer and a major killer of Americans. About 224,390 people in the U.S. are diagnosed with the disease each year and more than 150,000 die from it annually, according to the American Cancer Society.
Last week, Clovis said it’s expecting a rejection from the Food and Drug Administration by the end of June. It stopped enrolling patients into ongoing studies of the drug and pulled its European marketing application. Yet as pharmaceutical developers rush to find new treatments for the disease, rociletinib’s history is a case study in the ups and downs of drug development.
Last April, researchers from the phase 1 trial published an early estimate that rociletinib could fight lung cancer in 59 percent of patients with a specific mutation. The announcement caused excitement among oncologists and investors about a potential breakthrough. That optimism was reversed in November, when the Boulder, Colorado-based company said data combined from two studies found the benefit was significantly less, helping 28 percent to 34 percent of patients.
In fact, the drug’s effectiveness was somewhere in the middle, said the researchers. Among the 51 patients with the mutation, 45 percent had a confirmed response to the drug, they said. The original results were also published in the journal.
While good news for Clovis, the results aren’t enough to help the drug reach the market now, the researchers said. More study is needed to clarify its benefit, they said.
The data published today represent just a portion of the patients studied by Clovis and submitted to the FDA, said Anna Sussman, a company spokeswoman. Overall response rates ranged from 23 percent to 34 percent in larger trials, she said.
Rociletinib would compete with AstraZeneca Plc’s Tagrisso, which was approved in November for the same condition. In two clinical trials, 57 percent to 61 percent of patients getting the AstraZeneca drug had their tumors shrink or disappear completely.
The issue for rociletinib was the duration of the response. Patients were expected to undergo two scans to confirm if their tumors were shrinking. The initial publication followed patients for a little more than 10 weeks, before the majority of the patients had their second scan. The initial signs of regression didn’t persist in some patients once the second set of tests were completed, the researchers said.