#China #Chengdu #Kelun-Biotech #Tagitanlimab #Nasopharyngeal-Cancer

Kelun Biotech’s Tagitanlimab Approved for Metastatic NPC Treatment

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. recently announced a significant milestone: the National Medical Products Administration (NMPA) of China has granted marketing authorization for its humanized monoclonal antibody, Tagitanlimab. This innovative therapy is now approved for use in combination with cisplatin and gemcitabine as a first-line treatment for patients with recurrent or metastatic nasopharyngeal cancer (NPC).

Background of the Approval

The approval marks the second indication for Tagitanlimab, which was previously authorized for use as a monotherapy for NPC patients who had not responded to prior chemotherapy. The recent approval was based on compelling data from a randomized, double-blind, placebo-controlled Phase III clinical trial that highlights the efficacy and safety profile of Tagitanlimab.

The clinical study, led by Professor Shi Yuankai from the Cancer Hospital Chinese Academy of Medical Sciences, demonstrated that patients receiving Tagitanlimab in combination with standard chemotherapy experienced notable benefits compared to those receiving a placebo. Key results showed that the combination led to enhanced progression-free survival (PFS), a higher objective response rate (ORR), and a more extended duration of response (DoR).

Key Clinical Findings

Patients treated with Tagitanlimab plus cisplatin and gemcitabine displayed a progression-free survival rate not reached at the time of data analysis, contrasting sharply with the 7.9-month median PFS observed in the placebo group. The risk of disease progression and mortality was significantly reduced by 53%. Furthermore, the objective response rate was reported at 81.7%, compared to 74.5% in the control group. The median duration of response almost doubled, highlighting the superior effectiveness of this treatment modality.

While median overall survival (OS) data are still maturing, early trends suggest a beneficial effect, with a 38% reduction in the risk of death among patients receiving the new therapy. Importantly, Tagitanlimab exhibited a manageable safety profile, further supporting its potential as a frontline treatment option.

Future Implications

Dr. Micheal Ge, CEO of Kelun Biotech, expressed enthusiasm about the approval, noting the significant advancements Tagitanlimab brings to the treatment landscape for NPC patients. The company asserts that Tagitanlimab's integration into treatment protocols can offer a breakthrough in addressing unmet clinical needs for this patient population.

Looking ahead, Kelun Biotech is committed to harnessing innovation to develop new therapeutic solutions, aiming to enhance patient outcomes globally. The company maintains a strong pipeline with over 30 ongoing projects in innovative drug development, further reinforcing its position as a leader in this sector.

About Kelun Biotech

Founded as a subsidiary of Kelun Pharmaceutical, Kelun Biotech is dedicated to the research, development, and commercialization of cutting-edge biological and small molecule drugs. With a focus on treating significant medical diseases such as cancers and autoimmune disorders, the company continues to cultivate a comprehensive drug development platform that targets unmet medical demands in China and beyond.

Through a commitment to research excellence and patient-focused innovation, Kelun Biotech strives to emerge as a global frontrunner in the realm of innovative oncology treatments. For ongoing updates and additional information regarding their portfolio, interested parties can explore Kelun Biotech’s website.