InterMune ends trial of Actimmune for ovarian cancer after no benefits found

New York, Feb. 2 - InterMune, Inc. said it has stopped its Graces phase 3 clinical trial of Actimmune (interferon gamma-1b) with standard chemotherapy in patients with advanced ovarian cancer after no benefit was found.

The study had been comparing the safety and efficacy of Actimmune with carboplatin plus paclitaxel to carboplatin plus paclitaxel alone.

But the independent Data Safety Monitoring Board recommended halting the work after an interim analysis showed shorter overall survival time in patients who received the Actimmune treatment compared to carboplatin and paclitaxel alone.

In the Actimmune group, 169 patients out of 426 (39.7%) died compared to 128 out of 421 (30.4%) receiving chemotherapy alone.

There was no difference in progression-free survival time between treatment groups.

"We are disappointed that Actimmune in combination with carboplatin and paclitaxel did not benefit patients with ovarian cancer," said Steven Porter, chief medical officer of InterMune, in a news release.

"The results from this study suggest that Actimmune, which has generally been well-tolerated in studies across multiple disease states, may exacerbate the dose-limiting toxicities of cytotoxic chemotherapy drugs.

"Consequently, we have no plans to initiate further studies of Actimmune in oncology or in combination with such chemotherapy regimens."

But Porter added: "We remain very comfortable with the role of Actimmune monotherapy in our approved indications of chronic granulomatous disease and severe, malignant osteopetrosis, and we continue to be very enthusiastic about our ongoing clinical development program evaluating Actimmune alone for the treatment of idiopathic pulmonary fibrosis."

Enrollment in InterMune's phase 3 Inspire trial of Actimmune for idiopathic pulmonary fibrosis is expected to be completed in the first half of this year.

InterMune is a Brisbane, Calif., biotechnology company.

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