#China #Chengdu #Sacituzumab #NSCLC #Tagitanlimab

Groundbreaking Results in Treatment of NSCLC

A recent publication in Nature Medicine has unveiled exciting results from a Phase II clinical trial, detailing the efficacy and safety of a new combination therapy for advanced non-small cell lung cancer (NSCLC). The study, spearheaded by a team led by Professor Zhang Li at the Center for Cancer Prevention and Control, Sun Yat-sen University in China, investigates the combination of the novel TROP2 antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT) and the PD-L1 monoclonal antibody tagitanlimab.

This innovative treatment approach was designed for patients with advanced or metastatic NSCLC who lack actionable genomic alterations, aiming to provide an effective first-line therapy option. The study monitored two cohorts, with patients receiving either sac-TMT combined with tagitanlimab in different dosing intervals, allowing researchers to assess various response rates and safety profiles.

Significant Findings

Among the critical findings from the OptiTROP-Lung01 trial, the study reported that the objective response rates (ORR) varied impressively between the treatment groups. Cohort 1A displayed a response rate of 40.0%, while Cohort 1B boasted a remarkably higher 66.7%. This variance illuminates the potential for optimized dosages to impact therapeutic results positively. Notably, responses were observed across different cancer histologies such as squamous and non-squamous carcinomas, reinforcing the treatment's broad applicability.

The median progression-free survival (mPFS) was another significant highlight, marking 15.4 months for Cohort 1A, while Cohort 1B's mPFS remains undetermined, showcasing an elongating effect of the treatment on disease control.

Safety and Tolerability

Regarding safety, the treatment profile appeared manageable, with common grade ≥3 treatment-related adverse events (TRAEs) being a decrease in neutrophil and white blood cell counts alongside anemia. Encouragingly, no treatment-related fatalities were reported during the trial, bolstering the therapy's safety record.

Expert Insights

Dr. Michael Ge, CEO of Kelun-Biotech, expressed his optimism following these findings, underscoring the potential for sacituzumab tirumotecan combined with tagitanlimab to transition from a later-line therapy to a front-line treatment option. The study results represent not just a leap forward for Kelun-Biotech's research and development efforts but also a pivotal moment for NSCLC treatment as a whole.

About Sacituzumab Tirumotecan

Sacituzumab tirumotecan (sac-TMT) is a flagship product of Kelun-Biotech, developed using advanced technology to ensure effective targeting of advanced solid tumors. With proprietary intellectual property on its mechanism, sac-TMT serves as a beacon of hope for oncologists and patients alike, particularly for those battling NSCLC, breast cancer, and gastric cancer. The drug concept is built around a sophisticated linker that delivers a topoisomerase I inhibitor directly into tumor cells, facilitating targeted therapy while minimizing systemic damage.

In May 2022, Kelun-Biotech strategically licensed rights to MSD to widen the scope of sac-TMT’s deployment beyond Greater China, highlighting its commitment to addressing global unmet medical needs.

As an extension of its innovative approaches, Kelun-Biotech has initiated several clinical studies to further evaluate sac-TMT across various cancer types, demonstrating an unwavering dedication to enhancing patient outcomes and life quality through novel therapies.

Conclusion

The publication of these findings not only marks a significant advancement in oncology treatments but also illustrates the growing recognition of innovative strategies in the pharmaceutical industry to combat complex diseases like NSCLC. With continued research and collaboration, the future of cancer therapy looks increasingly promising.