Lurbinectedin

REDMOND, Wash., Aug. 5, 2026 /PRNewswire/ -- SystImmune, Inc., a clinical-stage biotechnology company and subsidiary of Biokin, today announced that the first patient has been dosed in BrenDeLL-Lung01 (NCT07625644), a global Phase 3 registrational trial evaluating BL-M14D1 in combination with atezolizumab for the treatment of patients with previously untreated extensive-stage small cell lung cancer (ES-SCLC). BL-M14D1 is an investigational DLL3-targeted antibody-drug conjugate (ADC) built on SystImmune's proprietary brengitecan platform and is being developed globally for the treatment of small cell lung cancer and other neuroendocrine malignancies. "The initiation of our global Phase 3 program marks an important milestone for BL-M14D1 and reflects our commitment to bringing innovative treatment options to patients with small cell lung cancer," said Jonathan Cheng, M.D., Chief Medical Officer of SystImmune. "Despite recent advances, outcomes for patients with extensive-stage small cell lung cancer remain poor, and there continues to be a significant need for more effective therapies. We believe BL-M14D1 has the potential to improve outcomes for these patients, and we are excited to begin evaluating the program in a registrational setting." The Phase 3 study follows encouraging clinical activity observed in the ongoing Phase 1 BL-M14D1-101 trial recently presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. These results demonstrated promising anti-tumor activity and a manageable safety profile in heavily pre-treated patients with small cell lung cancer and other neuroendocrine carcinomas, supporting advancement of the program into late-stage development. About the BrenDeLL-Lung01 Phase 3 Clinical Trial BrenDeLL-Lung01 (NCT07625644) is a global, multi-center, randomized Phase 3 trial evaluating BL-M14D1 in combination with atezolizumab versus standard-of-care platinum and etoposide induction followed by atezolizumab maintenance, with or without lurbinectedin, in patients with previously untreated extensive-stage small cell lung cancer. The study intends to enroll approximately 580 patients and the primary endpoint for this study is progression-free survival as assessed by blinded independent central review (BICR). About BL-M14D1 SystImmune is advancing a portfolio of next-generation antibody-drug conjugates (ADCs) built on its proprietary brengitecan platform, which utilizes a potent topoisomerase I inhibitor payload designed for targeted delivery to tumor cells. The clinical progress of izalontamab brengitecan (iza-bren) provides initial validation of this platform's potential to deliver meaningful anti-tumor activity across multiple cancer types. BL-M14D1 targets DLL3, which is highly expressed in small-cell lung cancer and neuroendocrine tumors, facilitating selective delivery of the brengitecan payload to DLL3-positive tumor cells. About SystImmune SystImmune is a clinical-stage biopharmaceutical company located in Redmond, WA. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has several assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development. Forward-Looking Statements This press release contains forward-looking statements, including statements regarding the potential clinical benefits of iza-bren, the timing and outcomes of regulatory interactions, and the future development and commercialization of iza-bren. Forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially. SystImmune undertakes no obligation to update any forward-looking statements contained herein, except as required by law. SOURCE SystImmune, Inc. 21% more press release views with Request a Demo

After a yearslong struggle, Jazz Pharmaceuticals has called time on Zepzelca as a second-line treatment for small cell lung cancer. In alignment with the FDA, Jazz plans to ask the agency to remove the second-line SCLC indication from Zepzelca’s label, the company said Monday alongside its second-quarter earnings report. The decision comes after the confirmatory phase 3 Lagoon trial recently failed on its primary endpoint of overall survival. In the study, Zepzelca (lurbinectedin) monotherapy performed even worse than other chemotherapy regimens, while a combination of Zepzelca and irinotecan showed a numerical advantage that didn’t meet statistical significance. The withdrawal does not affect Zepzelca’s first-line maintenance approval as part of a combination with Roche’s Tecentriq for patients with extensive-stage SCLC. Zepzelca’s troubles quickly began to show after its initial FDA go-ahead in second-line SCLC. Just half a year after accelerated approval, the PharmaMar-partnered drug failed in the randomized phase 3 Atlantis trial, which evaluated the chemotherapy in tandem with doxorubicin versus the physician’s choice of chemo in second-line SCLC. Despite the flop, the FDA allowed Zepzelca to remain on the market and, in 2022, rejected a citizen petition calling for its withdrawal. At the time, the agency noted that the Atlantis study used a lower dose of Zepzelca than its approved version, and that an unmet medical need exists in second-line SCLC. Since then, the agency has approved Amgen’s T-cell engager Imdelltra in previously treated SCLC. The Lagoon trial used standard-dose Zepzelca for its single-agent regimen. Commercially, the first-line maintenance nod has given Zepzelca a boost. Sales of the drug in the second quarter increased 42% year over year to $106 million, as Jazz attributed the growth solely to its first-line use. Still, second-line uses make up the majority of Zepzelca’s uptake, with around 30% to 40% of the drug’s U.S. sales coming from the first-line setting, according to Jazz’s chief commercial officer, Sam Pearce, on an investor call Monday. Even before the withdrawal decision, Jazz had already seen a gradual decline in its second-line business due to competition. Now, “we may expect that to accelerate,” Pearce said. Cancer drugmakers have mostly been cooperative in withdrawing their drugs or indications after the FDA ramped up its post-accelerated approval scrutiny in recent years. In 2022, GSK quickly announced plans to remove its antibody-drug conjugate Blenrep merely days after a confirmatory trial flop in third-line multiple myeloma. The British pharma managed to reintroduce the drug as part of a combination last year after new phase 3 wins. Other oncology market withdrawals in recent years as a result of confirmatory trial setbacks include Takeda’s EGFR inhibitor Exkivity in lung cancer, Gilead’s ADC Trodelvy in bladder cancer and Ipsen’s EZH2 inhibitor Tazverik in blood cancer.