Concure Oncology plans to use $2.5 million in new funding to help make its targeted radiation treatment option increasingly available to early-stage breast cancer patients. Specifically, the funding round is expected to allow Concure to double its field sales organization and to focus on training new clinicians nationwide on its Breast Microseed Treatment. Within the last…
Treatment with XMT-1536 appears to be safe, with promising responses shown in heavily pretreated patients with ovarian cancer and non-small cell lung cancer (NSCLC) adenocarcinoma in a Phase 1 clinical trial. Mersana Therapeutics’ XMT-1536 is an antibody-drug conjugate that works by delivering a toxic compound specifically to cancer cells containing a protein called sodium-dependent phosphate transport…
The U.S. Food and Drug Administration (FDA) has now given fast track status to Agenus’ balstilimab — both alone and in combination — as an immunotherapy candidate for advanced metastatic cervical cancer. This designation, given separately to these different treatment approaches, is meant to help speed its development by facilitating discussions with the FDA and enabling the therapy to qualify…
Bristol Myers Squibb and Bluebird Bio are seeking U.S. approval of their lead investigational CAR T-cell therapy — idecabtagene vicleucel (ide-cel; bb2121) — for the treatment of heavily pre-treated multiple myeloma. The companies have submitted a biologics license application to the U.S. Food and Drug Administration for ide-cel’s approval to treat adult patients, who have…
Keytruda (pembrolizumab) significantly extends survival without disease worsening in adults with relapsed or refractory classical Hodgkin’s Lymphoma (cHL), compared to treatment with Adcetris (brentuximab vedotin), interim data from a Phase 3 pivotal trial show. “Patients with classical Hodgkin lymphoma are generally young and when they do not achieve remission following standard treatment, their cancer is…
When trying to write this week’s column, I found myself coming up empty. To be honest, doing anything creative has been a struggle lately. “Mental molasses,” my friend Sarah described it. I suppose navigating through a state of disbelief every day can be stifling. My day starts at 8:30 a.m.; reluctantly I drag myself into…
Immunomedics has halted its Phase 3 confirmatory trial of sacituzumab govitecan, due to strong evidence of its ability to delay disease progression in patients with advanced triple-negative breast cancer (TNBC). Members of an independent data safety monitoring committee unanimously decided on an early stop to the ASCENT trial (NCT02574455), which was originally slated to end…
Senti Biosciences is working with RoosterBio to ensure a quality supply of its candidate gene-modified cell therapies for ovarian cancer and other solid tumors, with a goal of bringing them into clinical testing. These investigative therapies are based on the replacement, inactivation, or introduction of genes into cells that were cultivated or modified outside the body. The…
A Phase 3 clinical trial investigating Immunomedics‘ potential therapy sacituzumab govitecan is ending early because existing results have shown sufficient evidence that the treatment is effective in patients with triple-negative breast cancer (TNBC). The decision to stop the trial was unanimously recommended by an independent data safety monitoring committee. An application to obtain approval for…
Topline results show a 26% response rate in a Phase 2 clinical trial evaluating Ygalo (melflufen) in patients with triple-refractory multiple myeloma, a difficult-to-treat form of this disease, the therapy’s developer, Oncopeptides, announced. These data will support a request for accelerated approval for Ygalo to treat people with triple-refractory multiple myeloma in the U.S., the company said in a…
