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FDA Advisory Committee votes on accelerated approval for investigational medicine olaparib

On June 25, 2014 AstraZeneca reported that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 11 to 2 that current evidence from clinical studies does not support an accelerated approval for use of olaparib as a maintenance treatment for women with platinum-sensitive relapsed ovarian cancer who have the germline BRCA (gBRCA) mutation, and who are in complete or partial response to platinum-based chemotherapy (Press release AstraZeneca, JUN 25, 2014, View Source;zfda-advisory-committee-votes-on-accelerated-approval [SID:1234500602]).

The ODAC provides the FDA with independent, expert advice and recommendations, however the final decision regarding approval is made by the FDA.

AstraZeneca filed the US regulatory submission for olaparib in February 2014. The FDA granted priority review status for the NDA in April and set a Prescription Drug User Fee Act (PDUFA) action date of 3 October 2014.

Briggs Morrison, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca said: “Patients with germline BRCA-mutated serous ovarian cancer have few options available to treat this disease. We are disappointed with today’s recommendation, and strongly believe that olaparib has the potential to provide patients with relapsed BRCA-mutated ovarian cancer and their doctors with a much-needed treatment option. We look forward to continuing to work with the FDA as it evaluates the Advisory Committee recommendation and completes its review of the application. In the meantime, we are continuing with our Phase III clinical programme to evaluate the benefit of olaparib for this patient population. We aim to have completed this study by the end of 2015.”

The NDA filing was based on a subgroup analysis of Phase II data recently published in Lancet Oncology (Lancet Oncol. 2014 May 29. pii: S1470-2045(14)70228-1. doi: 10.1016/S1470-2045(14)70228-1. View Source). The Phase II study was a randomised, double-blind, placebo-controlled trial which evaluated olaparib versus placebo as maintenance treatment in platinum-sensitive relapsed serous ovarian cancer patients who had received previous treatment with at least two platinum regimens and were in a maintained partial or complete response following their last platinum regimen. The study met its primary endpoint of progression-free survival by Response Evaluation Criteria in Solid Tumours guidelines. A pre-defined subgroup analysis was conducted in patients who have germline BRCA mutations.

In addition, as part of its commitment to bring the potential benefits of olaparib to ovarian cancer patients, AstraZeneca has initiated and is committed to complete the Phase III SOLO programme, designed to evaluate the efficacy and safety of olaparib as a maintenance monotherapy in ovarian cancer patients who have a BRCA mutation who are in complete or partial response following platinum-based chemotherapy in the relapsed setting.

(Press release, Ligand, JUN 24, 2014, View Source [SID:1234502817])

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Johnson & Johnson Innovation Announces Immuno-Oncology Lung Cancer Collaboration with the Dana-Farber Cancer Institute’s Belfer Institute for Applied Cancer Science

On June 24, 2014 Johnson & Johnson Innovation, Boston and Janssen Biotech, Inc. reported a three-year immuno-oncology lung cancer collaboration with the Dana-Farber Cancer Institute (Press release Johnson & Johnson, JUN 24, 2014, View Source [SID:1234501614]). Through the collaboration, Janssen scientists will work with the research team at Dana-Farber’s Belfer Institute for Applied Cancer Science to determine the clinical setting for certain immuno-oncology agents in Janssen’s lung cancer discovery pipeline.

"We are thrilled to be working with the scientists at the Belfer Institute," said Peter Lebowitz, Janssen Global Therapeutic Area Head, Oncology. "Their excellence in lung cancer translational research, which incorporates both tumor genetics and immunotherapy, will be critical to the development of personalized treatment options for patients in need."

Utilizing the Belfer Institute’s proprietary immuno-oncology lung platform and lung cancer disease expertise, the research teams will also seek to identify rational immuno-oncology drug combination strategies and biomarkers, and to characterize mechanisms of resistance. The collaboration will also identify and validate novel targets for lung cancers.

"There is a growing recognition of the potential importance of immuno-oncology agents directed at a variety of cancers," said Robert G. Urban, PhD, Head of Johnson & Johnson Innovation, Boston. "Through our collaboration with the Dana-Farber Cancer Institute, we will be able to increase the probability of success and decrease development times for our important immuno-oncology pipeline in the critical area of lung cancer."

Lung cancer is one of three focus areas for Janssen Oncology based on its high unmet need. According to the American Cancer Society, lung cancer is the leading cause of cancer death among both men and women. Each year, more people die of lung cancer than of colon, breast, and prostate cancers combined. Overall, the chance that a man will develop lung cancer in his lifetime is about 1 in 13; for a woman, the risk is about 1 in 16.

Mersana and Merck KGaA of Darmstadt, Germany, to Develop Next-Generation Antibody-Drug Conjugates

On June 24, 2014 Mersana Therapeutics and Merck KGaA (EMD Serono) reported an agreement to collaboratively develop next-generation antibody-drug conjugates (ADCs) (Press release Mersana Therapeutics, JUN 24, 2014, View Source [SID:1234500605]). ADCs are composed of an antibody linked to cytotoxic drugs, whereby the antibody specifically targets and delivers the cytotoxic drug to cancer cells, which could lead to higher drug levels at the tumor site.

Mersana and the biopharmaceutical division of Merck KGaA will leverage Mersana’s Fleximer technology to generate ADCs for multiple undisclosed targets. Both parties have agreed to test a variety of ADCs by utilizing Mersana’s platform technologies and several cytotoxic agents as conjugates.

"This new collaboration provides an exciting opportunity to expand our oncology drug discovery and development portfolio into the evolving ADC space," said Dr. Andree Blaukat, head of the Translational Innovation Platform Oncology at Merck Serono, the biopharmaceutical division of Merck KGaA, Darmstadt, Germany. "We have a long-standing commitment to improving oncology care, and we aim to deliver the best benefit possible to patients. Partnering with Mersana allows us to incorporate cutting-edge research and technical excellence to enrich our pipeline."

"We look forward to working with Merck in Darmstadt, Germany, to apply our proprietary platform technologies to rapidly develop and demonstrate preclinical proof-of-concept of several customized, novel Fleximer-ADC candidates," said Timothy B. Lowinger, Ph.D., Mersana’s Chief Scientific Officer.

Under the agreement, Merck KGaA will provide monoclonal antibodies to Mersana, which will generate the Fleximer-ADCs and conduct drug discovery and preclinical development activities. Merck KGaA will be responsible for clinical development and commercialization of any products under an exclusive license from Mersana. In addition to an upfront payment, Mersana is eligible to receive milestones plus royalties on worldwide net sales of products.

Phase 3 First-Line Melanoma Study of Nivolumab, an Investigational PD-1 Checkpoint Inhibitor, Demonstrates Superior Overall Survival Compared to Dacarbazine; Study Stopped Early

On June 24, 2014 Bristol-Myers Squibb reported that a randomized blinded comparative Phase 3 study (NCT01721772) evaluating nivolumab versus dacarbazine (DTIC) in patients with previously untreated BRAF wild-type advanced melanoma was stopped early because an analysis conducted by the independent Data Monitoring Committee (DMC) showed evidence of superior overall survival in patients receiving nivolumab compared to the control arm (Press release Bristol-Myers Squibb, JUN 24, 2014, View Source [SID:1234500600]). Patients in the trial will be unblinded and allowed to cross over to nivolumab. The Company will share these data with health authorities.

“The outcome of CheckMate -066 is an important milestone in the field of immuno-oncology as it represents the first well-controlled, randomized Phase 3 trial of an investigational PD-1 checkpoint inhibitor to demonstrate an overall survival benefit,” said Michael Giordano, MD, Head of Oncology Development. “Bristol-Myers Squibb is committed to continuing to lead advances in immuno-oncology and to executing our strategy to provide patients with the best opportunity to achieve the potential for long term survival.”

CheckMate -066 investigators have been informed of the decision to stop the blinded comparative portion of the trial. Bristol-Myers Squibb will ensure that patients are informed of the opportunity to continue or start treatment with nivolumab in an open-label extension as part of the Company’s commitment to characterize long-term survival. The study, which was designed in consultation with the Committee for Medicinal Products for Human Use (CHMP), was primarily conducted in countries where DTIC is a commonly-used treatment in the first-line setting, including Canada, but not at U.S. trial sites. The Company will complete a full evaluation of the final CheckMate -066 data and work with investigators on the future presentation and publication of the results.