Turning our attention away from the all-intrusive pandemic (at least from the primary topics surrounding COVID-19), it’s good to take a minute from the turmoil of the virus to engage with something positive. The continual waves of uncertainty that drive COVID-19 may leave something positive in the disease’s painful wake, particularly for people with Alzheimer’s…
Conditions
Conditions
Early Success in Phase 3 Trial of Sacituzumab Govitecan in Triple-Negative Breast Cancer
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…
Partnership to Ensure Gene-modified Cell Therapies for Ovarian Cancer Trials
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…
Positive Results Support Early Halt to Phase 3 Trial Testing Sacituzumab Govitecan for TNBC
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…
Phase 2/3 Trial of Treatment for Agitation in Alzheimer’s to Conclude Early
Axsome Therapeutics is planning to complete its ADVANCE-1 clinical trial, evaluating AXS-05 as a treatment for agitation in Alzheimer’s disease, a few months earlier to ensure the safety of study participants during the COVID-19 pandemic. Topline results from this Phase 2/3 trial, which opened in 2017, are now expected in April or May, rather than later this…
Finding Beauty in the Brokenness
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…
Keytruda Prolongs Life Without Disease Worsening in Classical Hodgkin’s Lymphoma, Interim Data Confirm
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…
Bristol Myers, Bluebird Bio Seek FDA Approval of Ide-cel to Treat Advanced Multiple Myeloma
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…
Let’s Celebrate Togetherness While Flattening the Curve
“As iron sharpens iron, so one person sharpens another.” –King Solomon This COVID-19 journey has become a long one. Did any of us have an idea it would go this far? I doubt it, and yet here we are. Some of us might be a little worse for wear, but my hope is that we’re…
Balstilimab, Potential Cervical Cancer Treatment, Placed on Fast Track
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…
Antibody-drug Conjugate XMT-1536 Shows Promise for Ovarian Cancer in Phase 1 Trial
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…
Concure’s New $2.5M Funding to Boost Patient Access to its Radioactive Seed Treatment
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…