Adding AIVITA Biomedical’s experimental and personalized cancer vaccine, AV-GBM-1, to post-surgery standard treatment slows disease progression in adults newly diagnosed with glioblastoma — the most aggressive type of brain cancer — according to two-year data from a Phase 2 clinical trial. “The improvement in glioblastoma patients who were treated with AV-GBM-1, compared to studies with…
Janssen and Legend Biotech are seeking U.S. approval for their investigational CAR T-cell therapy ciltacabtagene autoleucel — known as cilta-cel — to treat adults with relapsed or refractory (hard-to-treat) multiple myeloma. A rolling submission of the biologics license application (BLA) for cilta-cel has been started by Janssen with the U.S. Food and Drug Administration (FDA).…
The investigational therapy cavrotolimod (AST-008), in combination with the PD-1 inhibitor Keytruda (pembrolizumab), was safe and well-tolerated, and showed signs of efficacy in people with advanced solid tumors who failed prior PD-1 blockade therapy, according to the interim results of a Phase 1b/2 clinical trial. Based on these findings from the Phase 1b stage, the…
ARV-110, an investigational oral therapy that degrades the androgen receptor, has a favorable safety profile and showed promising anti-tumor activity in heavily pretreated men with metastatic castration-resistant prostate cancer (mCRPC), updated Phase 1 data suggests. The approach worked particularly well in a population with specific mutations in the androgen receptor, the researchers said. But it…
InterVenn Biosciences has raised $34 million to commercialize a new diagnostic tool for ovarian cancer, based on the identification of circulating proteins containing sugar molecules (glycoproteins). The company expects to validate the diagnostic tool intended for immediate clinical use and drive rapidly expanding partnership projects. The funding will also help accelerate the use of glycoproteins in…
ARX788 has been given a fast track designation by the U.S. Food and Drug Administration as a monotherapy for patients with HER2-positive metastatic breast cancer previously treated with at least one anti-HER2-based regimen. The designation helps to accelerate the clinical development and expedite the approval of promising therapies for serious diseases, by providing more frequent…
The U.S. Food and Drug Administration (FDA) has granted the designation of breakthrough therapy to a combination of tiragolumab, a novel immunotherapy developed by Genentech, plus Tecentriq (atezolizumab) for the treatment of metastatic non-small cell lung cancer (NSCLC). The designation is intended to accelerate the development and review of medications that may be superior to…
Long-term exposure to androgen deprivation therapy (ADT), a common treatment for prostate cancer, is associated with worse cardiorespiratory fitness and a higher risk of cardiovascular death, a new study reports. Men who received ADT therapy for more than six months were ultimately found to have a nearly four times higher risk of death than those…
Rubraca (rucaparib) is superior to chemotherapy at prolonging life without disease worsening in people with advanced ovarian cancer who received at least two prior lines of chemotherapy, according to top-line data from an ongoing Phase 3 trial. Data from the study, called ARIEL4 (NCT02855944), also showed that Rubraca’s safety profile in these women, whose tumors contained…
The U.S. Food and Drug Administration (FDA) has approved a triple combination of Xpovio (selinexor) plus Velcade (bortezomib) and low-dose dexamethasone for the treatment of people with multiple myeloma who received at least one line of therapy. The approval, which comes three months ahead of deadline, was based on promising data from the BOSTON Phase…
