Owkin Inc. partnered with Astrazeneca plc to develop an artificial intelligence (AI)-powered tool to pre-screen for germline BRCA mutations (gBRCAm) in breast cancer directly from digitized pathology slides. The companies hope that the gBRCA pre-screening solution will not only transform patients’ lives but bring value to health care systems.
DNA polymerase θ (POLθ), repressed in somatic cells and overexpressed in several types of cancer, is crucial for DNA double-strand break repair during mitosis.
Insilico Medicine Inc. struck an out-licensing deal with Exelixis Inc. for its small-molecule USP1-inhibitor candidate called ISM-3091, the company said on Sept. 12, standing to gain $80 million in up-front payments.
Ideaya Biosciences Inc. has announced FDA clearance of an IND for a GSK-sponsored phase I/II trial of GSK-101 (IDE-705), a small-molecule inhibitor of Polϴ helicase, in combination with GSK's PARP inhibitor niraparib tosylate monohydrate for the treatment of tumors with BRCA or other homologous recombination mutations or homologous recombination deficiency.
The U.S. FDA’s Oncologic Drugs Advisory Committee has recommended by a wide majority that the PARP inhibitor Lynparza (olaparib) in a combination therapy for treating prostate cancer should be restricted to only patients whose tumors have a BRCA mutation.
The U.S. FDA’s Oncologic Drugs Advisory Committee meets April 28 to discuss the future of Astrazeneca plc and Merck & Co. Inc.’s supplemental NDA for Lynparza (olaparib) for an expanded label to treat prostate cancer. It has a few bones to pick. The FDA said it is concerned that the efficacy and safety have not been demonstrated outside of the small population of patients with tumor BRCA mutations and that the addition of olaparib to abiraterone may cause harm in patients who are definitively negative for tumor BRCA mutations.
Ovarian cancer is ordinarily associated with poor survival; patients diagnosed with high-grade serous ovarian carcinoma (HGSC) have an overall survival of about 40% at 5 years and 15% at 10 years. Despite having similar histologic features, HGSC patients often experience highly variable outcomes and the underlying determinants for long-term survival (LTS) are largely unknown. In a study published online in Nature Genetics, a multi-institutional group of researchers tried to determine the molecular differences that drive LTS in patients with HGSC.
Ovarian cancer is ordinarily associated with poor survival; patients diagnosed with high-grade serous ovarian carcinoma (HGSC) have an overall survival of about 40% at 5 years and 15% at 10 years. Despite having similar histologic features, HGSC patients often experience highly variable outcomes and the underlying determinants for long-term survival (LTS) are largely unknown. In a study published online in Nature Genetics, a multi-institutional group of researchers tried to determine the molecular differences that drive LTS in patients with HGSC.
Clovis Oncology Inc. is trying to claw its way into ovarian cancer relevance against vastly larger competitors Astrazeneca plc and Glaxosmithkline plc with positive top-line phase III data from its study of PARP inhibitor Rubraca (rucaparib). The study’s monotherapy arm of Rubraca as a first-line maintenance treatment of ovarian cancer hit the primary endpoint of significantly improved investigator-assessed progression-free survival (PFS) compared to placebo. The median PFS was 20.2 months for Rubraca compared to 9.2 months for placebo in the intent-to-treat group.
The American Society for Clinical Oncology’s (ASCO) virtual annual meeting began June 3 with the release of late-breaking abstracts, including LBA-1 on “Olympia: A phase 3, multicenter, randomized, placebo-controlled trial of adjuvant olaparib after (neo)adjuvant chemotherapy in patients with germline BRCA1 and BRCA2 mutations and high risk HER2-negative primary breast cancer.”
