Merck announced that KEYTRUDA, Merck’s anti-PD-1 therapy, has been approved by the National Medical Products Administration in combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer, with no EGFR or ALK genomic tumor aberrations. This new indication was granted conditional approval based on overall survival and progression-free survival data from the pivotal Phase 3 KEYNOTE-189 trial in patients regardless of PD-L1 tumor expression status. Continued approval may be contingent upon verification and description of clinical benefit in Chinese patients in a confirmatory trial. With this approval, KEYTRUDA is the first anti-PD-1 therapy approved for more than one tumor type in China, following its initial approval in July 2018 for advanced melanoma, and the first anti-PD-1 therapy approved in the first-line treatment setting for metastatic nonsquamous NSCLC.
Monday, April 1, 2019
Salix Pharmaceuticals enters license agreement with University Of California
Salix Pharmaceuticals announced its affiliate has entered into a license agreement with the University of California via UCLA’s Technology Development Group for certain intellectual property relating to an investigational compound targeting the pituitary adenylate cyclase receptor 1 in non-alcoholic fatty liver disease, non-alcoholic steatohepatitis and various other gastrointestinal and liver diseases.
Ziopharm announces fast track designation for controlled IL-12 program
Ziopharm announced that the FDA has granted fast track designation for its controlled IL-12 program, or Ad-RTS-hIL-12 plus veledimex, for the treatment of recurrent or progressive glioblastoma multiforme, or rGBM, in adults. Data previously presented suggest that Ad-RTS-hIL-12 with 20mg veledimex improves the median overall survival from six to nine months seen with available therapies to 12.7 months, with further improvement to 17.8 months in a subset of subjects with reduced cumulative steroid exposure during the active dosing period of veledimex.
Y-mAbs Therapeutics initiated at H.C. Wainwright
Y-mAbs Therapeutics initiated with a Buy at H.C. Wainwright. H.C. Wainwright analyst Raghuram Selvaraju started Y-mAbs Therapeutics with a Buy rating and $36 price target. The company has a “highly differentiated business model,” focusing on rare, hitherto difficult-to-treat pediatric cancers with next-generation monoclonal antibody therapeutics, Selvaraju tells investors in a research note. He believes the company’s is a platform “possesses multiple advantages.”
Cyclacel announces Phase 1 sapacitabine, seliciclib data at AACR
Cyclacel Pharmaceuticals announced Phase 1 clinical data from the company’s DNA damage response program with an oral, sequential regimen of sapacitabine and seliciclib as a treatment in patients with BRCA mutant metastatic breast cancer. Data from the study was presented at the American Association for Cancer Research, or AACR and demonstrated that the regimen was safe and led to a clinical benefit rate of 30%. All eight PARP inhibitor naive patients, half of the patients previously treated with platinum agents and one on previous PARP inhibitor responded. Progression on previous platinum or PARP inhibitors was associated with lack of benefit. Both sapacitabine and PARP inhibitors are more effective in cancer cells with BRCA mutations or other homologous recombination repair deficiencies. Based on these data, the investigators are enrolling a Phase 1b/2 study of sapacitabine in combination with a PARP inhibitor in PARP inhibitor-naive patients with BRCA mutant breast cancer. The study evaluated an oral, sequential regimen of sapacitabine, a nucleoside analog prodrug, and seliciclib, a first generation CDK2/9 inhibitor, in patients with metastatic breast cancer harboring BRCA1/2 mutations. Patients received seven days of sapacitabine followed by three days of seliciclib. Of 20 patients treated, six progressed on prior platinum therapy and seven on prior PARP inhibitor. Two patients achieved confirmed progressed response, or PR, and four SD of at least 6 months duration for an overall clinical benefit rate of 30%. Of the two patients achieving PR, one progressed previously on platinum treatment and one had received no prior platinum or PARP inhibitor. Responses occurred in 12 patients. The most frequent grade 3 adverse events were neutropenia, AST/ALT elevation and rash. The only grade 4 adverse events were neutropenia in two patients. Progression on previous platinum agents or PARP inhibitors was associated with lack of benefit, putatively associated in some cases with BRCA reversion alterations.
Biohaven Pharmaceutical enrolls first patient in Phase 2/3 Trial of BHV-3500
Biohaven Pharmaceutical announced that it enrolled the first patient in a Phase 2/3, double-blind, randomized, placebo-controlled, dose-ranging trial of intranasally administered BHV-3500 for the acute treatment of migraine. BHV-3500 is a novel, structurally distinct, third-generation calcitonin gene-related peptide receptor antagonist being developed by Biohaven. Topline efficacy and safety results are expected in the fourth quarter.
Ziopharm initiated with a Buy at Laidlaw
Laidlaw analyst Yale Jen initiated Ziopharm with a Buy and $7.50 price target.
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