The first participant has been dosed in a Phase 3 trial investigating a triple combination of melflufen (melphalan flufenamide) plus dexamethasone and under-the-skin Darzalex (daratumumab) in people with heavily treated multiple myeloma. The trial, dubbed LIGHTHOUSE (NCT04649060), had been delayed by the COVID-19 pandemic but is now recruiting an estimated 240 participants, ages 18 and…
ADP-A2M4, an investigational therapy that uses engineered immune cells to fight cancer, showed an acceptable safety profile and promising effectiveness in people with synovial sarcoma, a rare cancer that develops around the joints and tendons, new clinical trial data show. The findings were presented at the Connective Tissue Oncology Society (CTOS) annual meeting by trial…
The prescribing information for Nubeqa (darolutamide) — used to treat men with prostate cancer that has not spread to other parts of the body — will be updated to include overall survival data for patients with non-metastatic castration-resistant prostate cancer (nmCRPC), according to Bayer, one of the therapy’s developers. Specifically, data demonstrating that Nubeqa lowers…
Combining the experimental vaccine galinpepimut-S (GPS) with the immune checkpoint inhibitor Keytruda (pembrolizumab) induces promising responses in people with metastatic ovarian cancer who failed one or two prior lines of treatment, early data from a Phase 1/2 trial show. The combination kept all eight patients in a first evaluated group in the trial (NCT03761914) without signs…
Roche has launched a diagnostic genetic test to detect mutations in the PIK3CA gene in patients with advanced or metastatic breast cancer in the European Union. The cobas PIK3CA mutation test, performed in the lab (in vitro) and previously available for research purposes only, is now available in countries accepting the CE mark. “We are pleased to…
Phosplatin Therapeutics‘ investigational medication PT-112 showed promising efficacy and safety data in an early clinical trial of heavily-pretreated people with relapsed or refractory multiple myeloma. The findings were shared in a presentation, “A Phase I Dose Escalation Study of PT-112 in Patients with Relapsed or Refractory Multiple Myeloma,” at the 62nd American Society of Hematology (ASH)…
A couple of weeks after its approval, Orgovyx (relugolix) is now commercially available in the U.S. for adults with advanced prostate cancer through authorized specialty distributors, the therapy’s developer, Myovant Sciences, has announced. “Myovant has been focused on ensuring access to Orgovyx for men with advanced prostate cancer as quickly as possible following approval, and…
Lynparza (olaparib) has been approved in Japan as a maintenance treatment for women with advanced ovarian cancer who responded to a first-line chemotherapy regimen containing bevacizumab, AstraZeneca and Merck announced in a press release. The approval, for patients whose cancer is positive for homologous recombination deficiency (HRD), is based on data from the PAOLA-1 Phase 3 trial (NCT02477644),…
The Multiple Myeloma Research Foundation (MMRF) is partnering with Indapta Therapeutics to advance the biotechnology company’s investigational G-NK cell therapy into clinical trials for the treatment of multiple myeloma. The financial support for the therapy’s development is being given by the MMRF through an investment made via its venture philanthropy arm, the Myeloma Investment Fund.…
A breast cancer vaccine can now be tested in human trials after its investigational new drug application was accepted by the U.S. Food and Drug Administration (FDA). A Phase 1 clinical trial is expected to test the vaccine, developed by Anixa Biosciences and the Cleveland Clinic, for triple-negative breast cancer (TNBC). “We are pleased that…
