#China #Chengdu #Kelun-Biotech #NSCLC #EGFR-Mutant

Breakthrough in Lung Cancer Treatment: Sacituzumab Tirumotecan

Recently, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. announced noteworthy results from a registrational study evaluating sacituzumab tirumotecan (sac-TMT) for patients suffering from advanced EGFR-mutant non-small cell lung cancer (NSCLC). The findings were published in The British Medical Journal, renowned for its high impact factor of 93.6, underscoring the significance of this research in the medical community.

The study, known as OptiTROP-Lung03, was an open-label, randomized, multicenter trial that aimed to compare the efficacy and safety of sac-TMT monotherapy against the traditional drug docetaxel in patients who had previously undergone treatment with an EGFR-TKI and platinum-based chemotherapy.

Study Overview

With a total of 137 patients involved, participants were randomized into two groups: one receiving sac-TMT at a dosage of 5 mg/kg every two weeks and the other receiving docetaxel at 75 mg/m² every three weeks. The study maintained a median follow-up of 12.2 months, providing ample data to assess the treatment outcomes.

Results showed that sac-TMT achieved statistically significant improvements compared to docetaxel, such as:

• - Objective Response Rate (ORR): 45% for sac-TMT versus 16% for docetaxel.
• - Median Progression-Free Survival (PFS): 6.9 months for sac-TMT, markedly outpacing docetaxel's 2.8 months.
• - Overall Survival (OS): Data indicated that median OS could not be reached for sac-TMT, while preliminary analysis suggested promising outcomes for this treatment approach.

The results are compelling, as they demonstrate that sac-TMT effectively provided superior response rates and durability in disease control across all patient sub-groups assessed, including those with varying types of EGFR mutations and other clinical factors.

Safety Profile

In terms of safety, sac-TMT had a more favorable profile compared to docetaxel. Grade ≥ 3 treatment-related adverse events were reported at 56.0% for sac-TMT, compared to 71.7% for docetaxel, indicating a better tolerability for patients opting for sac-TMT therapy.

Future of Sac-TMT

This study represents a significant step in the battle against lung cancer, especially given that EGFR mutations are among the most prevalent genetic alterations in NSCLC. Dr. Michael Ge, CEO of Kelun-Biotech, emphasized the urgency for an effective treatment alternative that balances efficacy and safety, highlighting sac-TMT's potential to set a new standard of care in this patient population.

The approval of sac-TMT by the National Medical Products Administration (NMPA) earlier this March marked a historic milestone, being the first global approval of a TROP2 ADC specifically for lung cancer. The study's publication not only emphasizes the innovative treatment options emerging from Kelun-Biotech but also reinforces the pressing need for effective therapies catering to patients who have exhausted prior treatment avenues.

Continuing Research

Kelun-Biotech is committed to further exploring sac-TMT through multiple ongoing clinical trials aimed at evaluating its efficacy across various treatment settings, including earlier-stage adjuvant therapy strategies and inclusion in combination therapies with other agents.

In conclusion, with advancements demonstrated through the OptiTROP-Lung03 study, sac-TMT stands to reshape the landscape of treatment for patients afflicted with advanced NSCLC and represents a beacon of hope for many battling this challenging disease.