STCube announced on the 17th that it has completed Phase 1b of the Phase 1b/2 clinical trial of the anti-BTN1A1 immune checkpoint inhibitor candidate Nelmastobart for small cell lung cancer and has started Phase 2.
At the Data Safety Monitoring Board (DSMB) meeting held the previous day, STCube was recommended to continue the global Phase 1b/2 clinical trial of Nelmastobart. The DSMB is an official committee in the clinical trial protocol approved by regulatory agencies in each country, which evaluates safety and efficacy at interim points of the clinical trial and decides and recommends whether to proceed with the trial.
In Phase 1b, which aimed to confirm dose-limiting toxicity (DLT), a total of six patients were recruited. There were three patients each in the low-dose group (Nelmastobart 400mg, paclitaxel 175mg/m2) and the high-dose group (Nelmastobart 800mg, paclitaxel 175mg/m2). Patients received Nelmastobart and paclitaxel once every three weeks, and no dose-limiting toxicities or serious adverse drug reactions were observed in all six patients.
In the early stage of Phase 2, a total of 56 patients will be recruited, 28 per cohort. In the later stage, the recommended Phase 2 dose (RP2D) will be confirmed, and an additional 62 patients will be recruited to compare efficacy against a placebo group.
STCube confirmed the safety and efficacy of Nelmastobart monotherapy in the Phase 1 clinical trial completed last year. Currently, a global Phase 1b/2 clinical trial of Nelmastobart combined with paclitaxel is underway for second-line or later treatment of recurrent or refractory extensive-stage small cell lung cancer.
The Phase 1 trial recruited patients with advanced solid tumors such as colorectal cancer, with four small cell lung cancer patients enrolled. The disease control rate (DCR) of three small cell lung cancer patients evaluable for efficacy was 66.7%. Yonsei University College of Medicine Severance Hospital obtained approval from the Ministry of Food and Drug Safety in December last year for the compassionate use of Nelmastobart (hSTC810) for small cell lung cancer patients and is currently prescribing the drug.
An STCube official stated, “For small cell lung cancer patients in the Phase 1 trial receiving Nelmastobart under compassionate use, progression-free survival (PFS) has been confirmed to be over 18.87 months (1.57 years). Although this is compassionate use and the data are not reflected in the clinical trial, considering that the average PFS of drugs approved as second-line or later standard treatments for small cell lung cancer is only 3 to 3.5 months and overall survival is 6 to 9.3 months, this data is noteworthy.”
He added, “Even better results are expected in the Phase 1b/2 trial conducted in combination with standard chemotherapy. We expect Nelmastobart to bring meaningful changes to the lives of small cell lung cancer patients as a new treatment option.”
STCube began dosing the first patient in the Phase 1b/2 clinical trial of Nelmastobart for small cell lung cancer in February this year. The clinical trial institutions include nine centers such as Samsung Medical Center, Seoul National University Hospital, Bundang Seoul National University Hospital, Asan Medical Center, Korea University Anam Hospital, The Catholic University of Korea St. Vincent’s Hospital in Korea, and MD Anderson Cancer Center in the United States, with plans for further expansion.
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