Genentech says late-stage trial with Tarceva-Avastin meets primary endpoint - update

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Biotechnology company Genentech Inc. (DNA: [Only Registered users can see links . Click Here To Register...]), Monday announced that its late-stage trial of Tarceva in combination with Avastin met its primary endpoint. The company said that Tarceva-Avastin combination stopped lung cancer progression in the trial.

This positive news came as a great relief to Genentech, which is facing multiple threats like hostile takeover bid from Roche, and uncertain 2009 that the company called it "a difficult year to forecast."


Hal Barron, Genentech's senior vice president, Development and chief medical officer, said, "This is the second study to show that people with lung cancer who took the daily pill Tarceva following initial treatment lived longer without their cancer getting worse. We plan to discuss these data with the FDA to determine next steps."

The study showed that Tarceva in combination with Avastin as maintenance therapy stopped the progress of NSCLC significantly longer than taking Avastin alone.

Earlier, the study was stopped on the recommendation of an independent data safety monitoring board as the analysis showed that combining Tarceva and Avastin significantly extended the time patients lived without their disease advancing.

The phase III trial, called as ATLAS, is a global, multicenter, randomized, double-blind, placebo-controlled study that enrolled 1,157 patients with locally advanced, recurrent or metastatic non-small cell lung cancer or NSCLC.
Patients were initially treated with four cycles of Avastin in combination with a platinum-based chemotherapy regimens. If their cancer did not progress and they did not experience significant toxicity, patients were then randomized to receive maintenance therapy with Avastin plus Tarceva or Avastin plus placebo until disease progression.

The primary endpoint of the study was progression-free survival, which is the of time from randomization to disease progression or death from any cause. Secondary endpoints included overall survival, incidence of all adverse events and incidence of treatment discontinuation for reasons other than disease progression.

Tarceva is a once-a-daily pill that has been approved to treat lung and pancreatic cancer. The drug was developed by OSI Pharmaceuticals Inc. (OSIP: [Only Registered users can see links . Click Here To Register...]) and is sold by through partnerships with Genentech in the U.S. and with Roche throughout the rest of the world.

Another study, SATURN, also showed that Tarceva delayed disease progression when given as a single agent immediately following treatment with chemotherapy, compared to placebo.