“In the phase III head-to-head trial, Kyprolis in combination with dexamethasone doubled the time patients lived without their cancer progressing, as well as the rates of complete response compared to bortezomib and dexamethasone,” said Sean Harper, executive vice president of Research and Development at Amgen.
The EC approved the extended indication for Kyprolis based on data from the ENDEAVOR trial: patients with multiple myeloma treated with Kyprolis plus dexamethasone achieved superior progression-free survival of 18.7 months compared to 9.4 months in those receiving bortezomib plus dexamethasone (HR=0.53; 95% CI: 0.44, 0.65; p <0.0001). Kyprolis also demonstrated improvement in secondary endpoints, including rates of complete response or better, which were double in patients treated with Kyprolis, at 12.5 vs. 6.2 percent (p <0.0001).
The most common adverse reactions that occurred in greater than 20 percent of patients treated with Kyprolis were anemia, fatigue, diarrhea, thrombocytopenia, nausea, pyrexia, dyspnea, respiratory tract infection, cough and peripheral edema.
Kyprolis was first approved by the EC in November 2015 for use in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy based on results of the ASPIRE study. Today’s approval by the EC follows the FDA’s approval of a supplemental New Drug Application based on the ENDEAVOR results in January.
FDA granted seribantumab, also known as MM-121, a Fast Track designation for development in patients with heregulin-positive, locally advanced or metastatic non-small cell lung cancer, whose disease has progressed following immunotherapy.
Merrimack Pharmaceuticals, the drug’s sponsor, is conducting the SHERLOC trial, a global clinical study of seribantumab in combination with docetaxel or pemetrexed in heregulin-positive patients with NSCLC that is designed to support a Biologics License Application to the FDA. Seribantumab is Merrimack’s wholly owned, fully human monoclonal antibody that targets ErbB3.
“Heregulin-positive cancer cells are characterized by their ability to escape the effects of a broad range of cancer therapies and potentially contribute to accelerated disease progression. The SHERLOC trial is designed to advance the development of a much-needed treatment option for patients with heregulin-positive NSCLC after they progress on immunotherapies. This is important because we find that more than 50% of patients with NSCLC are heregulin-positive,” said Akos Czibere, vice president of clinical development at Merrimack.
SHERLOC is an open-label, multi-center, phase II study. Merrimack expects to enroll approximately 280 heregulin-positive patients who will be randomized to receive seribantumab in combination with either docetaxel or pemetrexed versus docetaxel or pemetrexed alone. Patients will be screened for heregulin status using a fully validated RNA-ISH assay. Eligible patients for the study must have failed prior treatment with no more than three lines of therapy including prior anti-PD-1 or anti-PD-L1 immunotherapy. The study’s primary endpoint is overall survival with secondary endpoints including progression free survival, objective response rate, and safety and quality of life measures.
FDA granted 510(k) clearance to the HARMONIC HD 1000i ultrasonic surgical device, developed by Ethicon, for use in open and laparoscopic procedures.
The shape of the device mimics a mechanical dissector, reducing the need to use a separate dedicated dissecting instrument, according to Ethicon. HARMONIC HD 1000i is designed for use in numerous procedures and specialties including hepato-pancreato-biliary, thoracic, colorectal, and gynecologic oncology.