The U.S. Food and Drug Administration (FDA) has approved Orgovyx (relugolix), an oral form of hormone therapy by Myovant Sciences, to treat adults with advanced prostate cancer. The approval, granted under priority review, was based on data from the HERO Phase 3 trial (NCT03085095), in which Orgovyx significantly increased the proportion of patients with sustained…

IMV‘s immunotherapy DPX-Survivac plus low-dose chemotherapy continues to show sustained benefits in people with heavily treated advanced ovarian cancer, with some benefits lasting up to 16 months, updated findings from a Phase 1/2 clinical trial show. These data “clearly support the relevance of DPX-Survivac as a potential new and much-needed treatment option for advanced recurrent ovarian…

PF-06863135, a bispecific antibody being developed by Pfizer as an injectable treatment, shows a manageable safety profile and promising response rates at high dose in heavily pre-treated patients with relapsed or refractory multiple myeloma, according to early data from an ongoing Phase 1/2 trial. “The very high response rate observed with PF-06863135, coupled with manageable…

The U.S. Food and Drug Administration (FDA) has granted the designation of breakthrough therapy to a combination treatment of IO Biotech’s lead anti-cancer vaccine candidates IO102 and IO103, plus an anti-PD-1 antibody-based immunotherapy, to treat patients with inoperable or metastatic melanoma. This designation is given to accelerate the development, review, and possible approval of medications…

Margenza (margetuximab-cmkb), in combination with chemotherapy, has been approved in the U.S. to treat adults with metastatic HER2-positive breast cancer who have previously received two or more anti-HER2 regimens, at least one of which was for metastatic disease. The therapy is expected to be launched in the U.S. in March, said the therapy’s developer, MacroGenics.…

Ciltacabtagene autoleucel, an investigational CAR T-cell therapy for multiple myeloma, continues to lead to deep and durable responses in heavily treated patients with relapsed or refractory disease, new data from the CARTITUDE-1 clinical trial show. The findings were shared recently in the oral presentation, “Phase 1b/2 Study of Ciltacabtagene Autoleucel, a B-Cell Maturation Antigen–Directed Chimeric Antigen Receptor…

Immunocore’s investigational immunotherapy tebentafusp (IMCgp100) is superior to investigator’s choice at prolonging the lives of adults newly diagnosed with metastatic uveal melanoma — a common and hard-to-treat form of eye cancer, interim data from a Phase 3 trial show. These preliminary findings add to the positive survival benefits reported with tebentafusp’s use in a Phase…

The philanthropic organization Prostate Cancer Foundation (PCF) and the charity Movember Foundation have announced the winners of the 2020 PCF Challenge Awards, an initiative that supports promising research in the pursuit of a cure for prostate cancer. The awards total $2 million, of which $792,000 came from the 2019 Movember U.S. Campaign and $477,000 were…

STRO-002, Sutro Biopharma’s experimental antibody-drug conjugate, continues to be safe and elicit promising responses in heavily pretreated patients with advanced ovarian cancer, according to the latest data from a Phase 1 clinical trial. Updated interim findings from the ongoing open-label study (NCT03748186) showed that 32% of women who were eligible for response analyses responded to…

BrickBio’s antibody-drug conjugate BRKB-28 showed preclinical effectiveness in eradicating breast cancer cells while leaving healthy cells unharmed, the company announced. BRKB-28 combines an antibody against a cancer protein with a toxic payload, using a linker molecule that connects the two. Once bound to its target, BRKB-28 releases its toxic compound into cancer cells, triggering their…

Researchers have developed a new technology that can be used to deliver the gene-editing tool CRISPR/Cas9 into prostate cancer cells without the need for viral vectors, a proof-of-concept study demonstrates. The study, “ZIF-C for targeted RNA interference and CRISPR/Cas9 based gene editing in prostate cancer,” was published in Chemical Communications. Cancer cells harbor genetic changes that…

A European Medicines Agency (EMA) committee has adopted a positive opinion on Bavencio (avelumab), recommending its approval as a first-line maintenance treatment for adults with locally advanced or metastatic bladder cancer (urothelial carcinoma) who have not progressed after platinum-based chemotherapy. The opinion, from the EMA’s Committee for Medicinal Products for Human Use (CHMP), will now…