March 24, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Kenilworth, N.J.-based Merck & Co. announced today that it had ended its pivotal Phase III KEYNOTE-006 clinical trial of Keytruda early due to meeting its two primary endpoints.
Keytruda (pembrolizumab) is a humanized monoclonal antibody being studied for the treatment of advanced melanoma. In KEYNOTE-006, the drug showed statistically significant and “clinically meaningful improvement in overall survival and progression-free survival compared to ipilimumab.”
“Evidence from our clinical program for Keytruda will help to define the appropriate treatment of advanced melanoma,” said Roger Perlmutter, president of Merck Research Laboratories in a statement. “We greatly appreciate the efforts of our investigators and their patients in this important study, and we look forward to the presentation of overall survival data from KEYNOTE-006 at the AACR annual meeting.”
The American Association of Cancer Research (AACR) Meeting will be held in Philadelphia on April 18-22.
The study was ended upon the recommendation of the independent Data Monitoring Committee. KEYNOTE-006 was evaluating the drug compared to ipilimumab in patients diagnosed with unresectable stage III or IV advanced melanoma who had no more than a single prior systemic therapy.
Keytruda targets PD-1, a programmed death 1 receptor. The PD-1/PD-L1 pathway has been identified in cancer as important in helping tumors avoid being destroyed by the body’s immune reaction. Scientists and physicians believe compounds that disrupt the pathway show great promise for certain types of cancer therapy.
Bristol-Myers Squibb announced on March 4, 2015 that it was developing and marketing Prostvac, Bavarian Nordic ’s investigational Phase III prostate-specific antigen (PSA)-targeting cancer immunotherapy for prostate cancer. Bristol-Myers is planning a phase II study that investigates a combination of Prostvac with the company’s Yervoy, which is a PD-1 inhibitor.
In late 2014 the U.S. Food and Drug Administration (FDA) approved Opdivo (nivolumab), also a PD-1 pathway inhibitor, accelerated approval for the treatment of metastatic melanoma. It was also granted breakthrough designation, priority review and orphan product designation. Opdivo is commercialized by Bristol-Myers Squibb.
In this most recent study, Keytruda was compared to Bristol-Myers Squibb’s Yervoy (ipilimumab). Keytruda is currently approved for treatment for patients with advanced melanoma that were treated with Yervoy previously. This so-called “second and third-line status” has changed with the results of the KEYSTONE trial, which will make Keytruda eligible as a first-line treatment, which could significantly expand Merck’s market.
Opdivo, Bristol-Myers Squibb’s competing product, recently gained approval for the treatment of squamous non-small cell lung cancer (NSCLC). This is an indication Merck is also proving for Keytruda usage.
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