Articles related to CLINICAL TRIALS

Copiktra (duvelisib), an oral inhibitor of phosphoinositide 3-kinase (PI3K), is indicated for the treatment of adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least 2 prior therapies. Based on the results of a clinical trial evaluating the long-term effects of the drug, the FDA recommends that health care providers evaluate the risks and benefits of continuing Copiktra vs. prescribing an alternative therapy.

Although the study did not meet its primary end point, the results of secondary analyses suggested a progression-free survival benefit with durvalumab plus olaparib in patients whose tumors harbor mutations in homologous recombination repair genes.

The addition of the PD-1 inhibitor serplulimab to chemotherapy significantly prolonged survival compared with chemotherapy alone as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC). Interim analysis of the phase 3 ASTRUM-005 study – comparing serplumimab plus chemotherapy to chemotherapy alone in 1st line extensive stage SCLC – showed a median OS of 15.4 months with serplulimab compared with 10.9 months with placebo. Patients who received serplulimab also had significantly longer median progression-free survival (PFS) 5.8 vs. 4.3 months respectively. The study included 585 patients with untreated extensive stage-SCLC, were randomized 2:1 to serplulimab (4.5 mg/kg) or placebo every 3 weeks. All patients received carboplatin and etoposide every 3 weeks for up to four cycles.

Immune checkpoint inhibitor (ICI)-refractory cancers are arguably one of the greatest unmet needs in oncology. In this randomized phase II substudy, patients ineligible for a biomarker-matched previously treated with ICI and platinum-based chemotherapy and progressive disease at least 84 days after initiation of ICI were randomly assigned to receive ramucirumab plus pembrolizumab (RP) or investigator’s choice standard of care (SOC: docetaxel/ramucirumab, docetaxel, gemcitabine, and pemetrexed). The study’s primary objective was to compare overall survival (OS). The median OS was 14.5 months for RP and 11.6 months for SOC. Docetaxel and ramucirumab were the most common SOC, received by 2/3 of patients. This randomized phase II trial demonstrated significantly improved OS with RP compared with SOC in patients with advanced NSCLC previously treated with ICI and chemotherapy.

This report includes 3-year follow-up of the pivotal ZUMA-2 study of KTE-X19 in relapsed/refractory MCL. At a median follow-up of 35.6 months, the objective response rate among all 68 treated patients was 91%, with 68% complete responses. Medians for duration of response, progression-free survival, and overall survival were 28.2 months, 25.8 months, and 46.6 months, respectively. “These data, representing the longest follow-up of CAR T-cell therapy in patients with MCL to date, suggest that KTE-X19 induced durable long-term responses with manageable safety in patients with relapsed/refractory MCL and may also benefit those with high-risk characteristics.”

Dr. Mohyudding summarizes key findings ASCO reports, including updates on teclistamab in CAR-T, the DETERMINATION trial assessing auto-transplantation, cilta-cel (covered by HCN here), and the ATLAS study evaluating carfilzomib with lenalidomide and dexamethasone as maintenance vs. lenalidomide alone.