November 17, 2015
By Alex Keown, BioSpace.com Breaking News Staff
BOULDER, Colo. -- Clovis Oncology ’s plummeted approximately 70 percent after the U.S. Food and Drug Administration (FDA) requested additional efficacy data about its lung cancer treatment rociletinib. But Clovis’ bad news is good news for AstraZeneca , which saw its new treatment for non-small cell lung cancer, Tagrisso, approved by the FDA on Nov. 17—three months ahead of schedule.
Analysts have predicted Tagrisso will generate about $3 billion in revenue at its peak. Tagrisso was approved for the treatment of patients with metastatic epidermal growth factor receptor T790M mutation-positive non-small cell lung cancer. A month’s treatment is expected to have a price tag of $12,750, which is comparable to other lung treatments such as Pfizer Inc. ‘s Xalkori and Novartis ‘s Zykadia, Reuters reported. Since the FDA approved Tagrisso, AstraZeneca has seen a bump in its stock from $31.29 per share to $33.28 per share.
FDA-approved tests have indicated Tagrisso as the first medicine for patients who have already been treated with an EGFR-blocking medication.
Clovis was expecting the FDA to rule on rociletinib sometime after the turn of the New Year, but the request for additional efficacy data likely pushes approval date back, which gives Tagrisso more time to become an established treatment. Not only will it have to compete with Tagrisso, but several other pharmaceutical companies are developing treatments for non-small cell lung cancer, including Genentech , which has seen its investigational oral medications shrink tumors in clinical trials. In March, the FDA approved Bristol-Myers Squibb Company ’ Opdivo for treatment of patients with metastatic squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy.
Clovis said the confirmed response rate for the 500 milligram dose of rociletinib was 28 percent and the rate for the 625 milligram dose was 34 percent. In contrast, Tagrisso’s response rate was above 50 percent in a Phase I trial and nearly 60 percent in two Phase II trials, AstraZeneca said.
During trials, Clovis said in a statement it presented the FDA with “interim data publicly and at medical meetings and these data therefore included a data set based primarily on unconfirmed responses.”
“This was also true of the company’s Breakthrough Therapy designation submission. In the company’s NDA submission, both immature confirmed and unconfirmed response analyses were submitted. As the efficacy data have matured, the number of patients with an unconfirmed response who converted to a confirmed response was lower than expected,” Clovis said.
After the FDA’s data request, Clovis’ stock tumbled from $99.52 on Friday to a low of $27.13. The plummeting value of the company could make Clovis a target for acquisition, a bidnessetc report noted this morning. The report suggested one potential suitor could be Gilead Sciences, Inc. , which has, according to the report, been looking to “expand in other treatment markets.” Clovis does not yet currently have a product on the market.
The FDA accepted Clovis’ New Drug Application for the experimental oncology drug and granted it priority review status, which is expected sometime in March of 2016. Clovis has also sought marketing authority with the European Medicine’s agency.
AstraZeneca has been developing multiple immuno-oncology treatments and this year has moved deeper into the field. In January, AstraZeneca tapped Robert Iannone as the head of its immuno-oncology development programs.
Earlier this year, AstraZeneca was forced to halt two clinical trials testing the combination of Tagrisso and durvalumab for lung cancer following reports of interstitial lung disease-like reports in one trial. In June, AstraZeneca submitted marketing authorization to the U.S. Food and Drug Administration. Earlier the FDA gave priority review to Tagrisso. Durvalumab is a monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumors avoid detection by the immune system.
