Immunomedics Reports Positive Phase 3 Data for Cancer Drug
Immunomedics Inc. (IMMU) reported that its confirmatory Phase 3 ASCENT study met its primary endpoint. The trial aimed to test Trodelvy for treating brain metastasis negative patients with mTNBC who have previously received at least two prior therapies for metastatic disease. Trodelvy is the first antibody-drug conjugate to show improved clinical outcomes in such patients.
Trodelvy showed a statistically significant improvement in the primary endpoint pertaining progression free survival compared to chemotherapy. The median PFS for treatment arm was 5.6 months while the control arm had median PFS of 1.7 months. Dr. Loretta M. Itri, Chief Medical Officer of Immunomedics, said, “Given the poor prognosis associated with mTNBC, we are excited that Trodelvy demonstrated improved clinical outcomes for these patients.”
The drug candidate also met its key secondary endpoints for the trial. These endpoints included overall survival and objective response rate. Aditya Bardia, MD, MPH, Assistant Professor of Medicine at Harvard Medical School, said, “The results of the global Phase 3 ASCENT study confirm our initial observations that sacituzumab govitecan has the potential to change the standard management of mTNBC. Based on these data, sacituzumab govitecan has set a new benchmark in scientific and clinical innovation for patients with mTNBC by offering a novel alternative to the common drugs currently in clinical practice.” He added that the topline data backs up the safety profile of sacituzumab govitecan.
Trodelvy showed its safety profile to be largely in line with previous findings. The trial did not demonstrate any new safety signals. Neutropenia and diarrhea were the most common Grade 3 or 4 adverse events occurring during the trial. Trodelvy carries a black box warning for severe neutropenia and severe diarrhea. Two percent of patients had to discontinue treatment due to adverse events.
Trodelvy was recently given a positive nod by the FDA as a third line treatment for adult patients suffering from mTNBC. The approval was given under the FDA’s Accelerated Approval Program. The endorsement was backed by Trodelvy’s objective response rate and duration of response noted in a Phase 2 study. ASCENT was designed following an FDA Special Protocol Assessment for confirming the promising safety and efficacy activity of the drug candidate that endorsed its accelerated approval.
ASCENT is an international, open label trial with more than 500 patients enrolled in it. These patients were randomized to receive either Trodelvy or a physician’s choice of chemotherapy. Its key secondary endpoints included overall survival, objective response rate, duration of response, time to onset of response along with other markers of tolerability and safety.
Trodelvy or sacituzumab govitecan-hziy is the lead drug candidate for Immunomedics. It is the most advanced program from the company’s antibody-drug conjugate (ADC) platform. The drug candidate is directed against Trop-2, which is a cell-surface protein involved in several solid cancers. Trodelvy works by binding itself to Trop-2 and delivering the anti-cancer drug to kill cancer cells. This drug candidate is being developed for a variety of indications including hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer, metastatic non-small cell lung cancer and triple-negative breast cancer, either as a monotherapy or in conjunction with other agents.
ADC Therapeutics Gets FDA Relief for Phase 2 Trial
ADC Therapeutics (ADCT) reported that the FDA has lifted partial clinical hold on its Phase 2 trial of Camidanlumab Tesirine. The trial aims to assess the drug candidate for treating patients suffering from relapsed or refractory Hodgkin lymphoma. A partial clinical hold generally results in halting of recruitment while allowing the current patients to keep receiving the treatment.
The phase 2 clinical trial is a multi-center, open-label, single-arm clinical study. It involves over 100 patients suffering from pathologically confirmed relapsed or refractory HL who have failed three prior lines of therapy, including brentuximab vedotin and a checkpoint inhibitor approved for HL. The company is looking to use the data from the trial to support its Biologic License Application to the FDA.
Camidanlumab tesirine, formerly ADCT-301, is an antibody drug conjugate. It consists of a monoclonal antibody conjugated to the pyrrolobenzodiazepine dimer payload, tesirine. Jay Feingold, MD, Ph.D of ADC Therapeutics, said, “The ADC Therapeutics team worked diligently to provide a thorough and prompt response to the FDA following its request for information about our pivotal Phase 2 clinical trial of Cami.” He added that the company continued to treat patients benefiting from the drug candidate during the partial clinical hold.
Cami works by binding itself to a CD25-expressing cell and then being internalized into the cell, causing an immunogenic cell death. The antibody drug conjugate may also diminish CD25-positive regulatory T cells in the tumor environment. Due to these features, Cami has the potential to fortify immune-mediated anti-tumor activity. The drug candidate is also the subject of another Phase 2 trial for patients with relapsed or refractory Hodgkin lymphoma. It is also in a Phase 1a/1b clinical trial for treating relapsed or refractory HL and non-Hodgkin lymphoma.
BELLUS Health Reports Disappointing Topline Data for Phase 2 Relief Trial
BELLUS Health Inc. (BLU) suffered a setback as its lead drug candidate BLU-5937 failed to meet primary endpoint of the trial for refractory chronic cough with statistical significance. However, the drug candidate was found to be well tolerated and no serious adverse events were reported. There were also no withdrawals on account of treatment-related adverse events at any dose level.
The primary endpoint for the Phase 2 RELIEF trial was the reduction in placebo-adjusted cough frequency at any dose tested. BLU-5937 did not attain statistical significance for the primary endpoint. However, in a pre-specified sub-group of high cough count patients, BLU-5937 demonstrated a clinically meaningful and highly statistically significant placebo-adjusted reduction in cough frequency. The group consisted of patients who had at or above the baseline median average of 32.4 coughs per hour.
The drug candidate was well tolerated. The occurrence of taste effects including partial taste loss and taste alteration was infrequent for all dose levels. Roberto Bellini, CEO of BELLUS Health, said, “In the RELIEF trial, we observed data that we believe is competitive within the P2X3 class, including the reduction in cough frequency shown in patients with higher cough counts and a low taste effect.” He added that the drug candidate is likely to be more beneficial to the patients with a greater disease burden.
The RELIEF trial is a dose-escalation, placebo-controlled, and crossover study. The trial aimed to evaluate the efficacy, safety and tolerability of BLU-5937 at four different dose levels of 25, 50, 100 and 200mg. The trial involved 68 patients across 16 sites in the United States and the UK. The trial had total 16 patients dropping out of the study.
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