On April 28, 2014 Teva and OncoGenex reported results from the Phase III SYNERGY trial (NCT01188187), a randomized, open-label, two-arm study comparing the combination of custirsen and standard first-line docetaxel/prednisone therapy to docetaxel/prednisone alone in men with metastatic castrate-resistant prostate cancer (CRPC) (Press release Teva, APR 28, 2014, View Source [SID:1234500475]).
Top-line survival results indicate the addition of custirsen to standard first-line docetaxel/prednisone therapy did not meet the primary endpoint of a statistically significant improvement in overall survival (OS) in men with metastatic CRPC, compared to docetaxel/prednisone alone (median survival 23.4 months vs 22.2 months, respectively; hazard ratio 0.93 and one-sided p-value 0.207).
The adverse events (AEs) observed for custirsen were similar to its known AE profile.
Full efficacy and safety data from SYNERGY will be submitted for presentation at an upcoming scientific conference.

On April 28, 2014 Agenus reported that the company has entered into a collaboration and license agreement with Merck & Co through a subsidiary, for the discovery and development of therapeutic antibodies to immune checkpoints for the treatment of cancer (Press release Agenus, APR 28, 2014, View Source [SID:1234500473]). Under the terms of the agreement, Agenus will discover and optimize fully human antibodies against two undisclosed Merck checkpoint targets using the 4-Antibody Retrocyte Display platform. Merck will be responsible for clinical development and commercialization of candidates generated under the collaboration.
Under the terms of the agreement, Agenus is eligible to receive approximately $100 million in potential payments associated with the completion of certain clinical, regulatory and commercial milestones for two candidates from Merck. In addition, Agenus is eligible to receive royalty payments on worldwide product sales.

On April 24, 2014 AstraZeneca reported that AZD9291 has been granted Breakthrough Therapy designation by the US FDA for the treatment of patients with metastatic, EGFR T790M mutation-positive, non-small cell lung cancer (NSCLC) whose NSCLC has progressed during treatment with an FDA-approved, EGFR tyrosine kinase inhibitor (Press release AstraZeneca, APR 24, 2014, View Source;first-quarter-results-2014 [SID:1234500464]).