KELUN-B (06990.HK): Two Registration Studies Selected for Oral Presentations at 2026 ASCO; Sac-TMT Shows Stellar Frontline NSCLC Data

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (06990.HK; Short Name: KELUN-B) issued an announcement on May 22 stating that the company will unveil multiple company-led clinical research achievements at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held from May 29 to June 2, 2026, in Chicago, Illinois, USA. Notably, two registration studies have been selected for the Oral Presentation sessions on metastatic non-small cell lung cancer (NSCLC): one for sacituzumab tirumotecan (sac-TMT; brand name: Jiatailai®), a human trophoblast cell-surface antigen 2 (TROP2)-targeting antibody-drug conjugate (ADC), and the other for lemborertinib fumarate (A400/EP0031; brand name: Ningtailai®), a next-generation selective rearranged during transfection (RET) inhibitor.

According to the announcement, the randomized, controlled Phase 3 study (OptiTROPLung05) evaluating sac-TMT combined with pembrolizumab versus pembrolizumab alone as a first-line treatment for PD-L1-positive advanced NSCLC enrolled a total of 413 patients who had received no prior systemic therapy. Patients were randomized in a 1:1 ratio. The results showed that, based on Blinded Independent Central Review (BICR) assessment, the combination group significantly prolonged progression-free survival (PFS) compared to the monotherapy group. The median PFS was Not Reached (NR) vs. 5.7 months, with a hazard ratio ($HR = 0.35$; 95% confidence interval ($CI$): 0.26–0.47; $p < 0.0001$). The objective response rate (ORR) was 70.2% vs. 42.0%. Overall survival (OS) data are immature but show a positive trend of benefit ($HR = 0.55$; 95% $CI$: 0.36–0.85). Based on the results of this study, the supplemental New Drug Application (sNDA) has been accepted by the National Medical Products Administration (NMPA) of China and granted Priority Review.

The pivotal Phase 2 study of lemborertinib fumarate for the treatment of patients with advanced RET fusion-positive NSCLC enrolled a total of 71 pretreated patients and 92 treatment-naïve patients. The results showed that the Independent Review Committee (IRC)-confirmed ORR was 87.1% in pretreated patients and 81.3% in treatment-naïve patients. The median PFS for pretreated and treatment-naïve patients was 27.5 months and Not Reached (NR), respectively, with 24-month PFS rates at 52.1% and 59.9%, respectively. Among patients with baseline brain metastases, the ORR reached 82.6% and 75.0%, respectively. Based on these study findings, its New Drug Application (NDA) has been accepted by the NMPA.

In addition, the results from the open-label, first-in-human study of SKB500 in patients with locally advanced or metastatic solid tumors will be presented in a Rapid Oral Presentation session on June 2, local time.

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