Combining two experimental cancer vaccines with Libtayo (cemiplimab) promotes strong anti-tumor immune responses and shows early signs of effectiveness in adults newly diagnosed with glioblastoma — the most aggressive type of brain cancer — according to interim data from a Phase 1/2 trial. Developed by Inovio Pharmaceuticals, the DNA-based vaccines, called INO-5401 and INO-9012, are…
The Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency, has recommended the conditional approval of trastuzumab deruxtecan (DS-8201) for the treatment of patients with inoperable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens. The therapy, which has received accelerated assessment in Europe, already has been approved in Japan…
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…
