Merck’s Chinese partner Kelun-Biotech has reported positive Phase 3 data for sacituzumab tirumotecan (sac-TMT), showing improved outcomes when the TROP2 antibody-drug conjugate (ADC) was combined with Keytruda in previously untreated locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with certain gene mutations.
The findings come from the Phase 3 OptiTROP-Lung05 study, which was detailed in an abstract released ahead of the American Society of Clinical Oncology (ASCO) Annual Meeting, scheduled to begin on May 29 in Chicago. The trial evaluated sac-TMT in 413 Chinese patients with previously untreated locally advanced or metastatic NSCLC with certain gene mutations. In the study, sac-TMT was added to a regimen with Keytruda, while the placebo group received the immunotherapy alone.
According to Kelun, treatment with sac-TMT resulted in a 70% objective response rate (ORR), while progression-free survival (PFS) was significantly improved compared with placebo. At the cutoff point of 10.5 months, median PFS had not yet been reached in the sac-TMT treatment group. By comparison, patients receiving Keytruda alone had a median PFS of 5.7 months.
Kelun also said that overall survival (OS) data remained immature, though the company reported a positive trend.
The OptiTROP-Lung05 findings mark the second positive readout for sac-TMT this week, ahead of ASCO. On May 18, Merck announced that the ADC demonstrated significantly improved overall survival and progression-free survival in patients with late-stage endometrial cancer.
Leerink Partners highlighted the objective response rate observed in the NSCLC trial, stating that it “compares favorably” to chemotherapy combined with Keytruda, which achieved response rates of approximately 56% to 58% in the same patient population.
The investment firm also pointed to progression-free survival results among patients with high PD-L1 expression, stating that these findings “confirm the superiority of the doublet over global standard-of-care” Keytruda.
“For us, details in the abstract are sufficient to drive MRK upside of +5%, given sac-TMT is one of the few internal programs broad enough to drive more certain growth through the Keytruda [loss of exclusivity] period and investors have been relatively lackluster about the program,” Leerink wrote in a note to investors.
Kelun also reported safety findings from the study. Treatment-emergent adverse events grade 3 or under occurred in more than half of patients receiving sac-TMT. By comparison, 31% of patients in the Keytruda-only group experienced such side effects.
Despite the positive results, Leerink said the first-line NSCLC setting would be difficult to enter because of expected competition. The firm described the findings as supportive of a broader TROP2 ADC plus immunotherapy strategy in first-line NSCLC, while also noting that the treatment area presents a high bar.
Leerink compared the findings with competing programs, including AstraZeneca’s Dato-DXd, which achieved a 55% objective response rate when combined with Keytruda in the Phase 1b TROPION-Lung02 study. The firm also discussed Akeso’s ivonescimab, which could compete in the same lung cancer indication, and Merck’s MK-2010, a VEGF-A/PD-1 therapy that could potentially be paired with sac-TMT in future combinations.
Merck signed a licensing agreement with Kelun, a subsidiary of Sichuan Kelun Pharmaceutical, in December 2022 worth up to $9.3 billion. Under the agreement, Merck obtained seven ADC programs, while Kelun retained development rights in China. Sac-TMT has also previously shown a survival benefit in gastric cancer.
Kelun Reports Positive Phase 3 Results for sac-TMT With Keytruda in First-Line NSCLC
Kelun has revealed encouraging Phase 3 clinical trial results for sac-TMT in combination with Keytruda as a first-line treatment for patients with advanced non-small cell lung cancer (NSCLC). The findings represent an important milestone for Kelun as the company continues to expand its presence in the highly competitive oncology market.
Kelun Achieves Key Clinical Trial Milestone
According to the study results, Kelun demonstrated that sac-TMT combined with Keytruda significantly improved progression-free survival compared with standard treatment options. The positive outcome highlights the potential of Kelun’s antibody-drug conjugate (ADC) platform to enhance treatment effectiveness for patients with advanced lung cancer.
How Kelun’s sac-TMT Therapy Works
The innovative therapy developed by Kelun utilizes targeted ADC technology to deliver cancer-fighting agents directly to tumor cells while minimizing damage to healthy tissue. When paired with immunotherapy, the approach aims to strengthen anti-tumor activity and improve patient outcomes. The latest data suggest that Kelun may have a promising new treatment option for first-line NSCLC patients.
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