Junshi Biosciences' JS207 Receives FDA Approval for Phase II/III Clinical Trial in Neoadjuvant Therapy of Non-Small Cell Lung Cancer

Strategic Insights -

Researchers have been working tirelessly to combat the rising incidence of lung cancer, a leading cause of morbidity and mortality worldwide. Among the various subtypes of lung cancer, non-small cell lung cancer (NSCLC) accounts for approximately 85% of all cases, with a significant proportion of patients still relapsing after undergoing radical surgery. To address this unmet clinical need, Junshi Biosciences has been developing JS207, a PD-1/VEGF bispecific antibody, as a potential treatment option for resectable NSCLC.

Key Takeaways:

  • The U.S. FDA has approved Junshi Biosciences to conduct a Phase II/III clinical trial of JS207 for neoadjuvant therapy of non-small cell lung cancer, making it the first confirmatory study approved for a PD-1/VEGF bispecific antibody in a resectable population.
  • The study will be led by Professor Wu Yilong of Guangdong Provincial People's Hospital as the principal investigator.
  • JS207 has been used in proof-of-concept studies targeting high-incidence tumors globally and in China and is a high-potential product in Junshi Biosciences' next-generation tumor immunotherapy pipeline.
  • The study aims to compare the efficacy and safety of JS207 versus nivolumab as neoadjuvant therapy in patients with stage II/III, resectable, AGA-negative NSCLC.
  • This study will contribute to the development of cutting-edge innovative therapies for resectable NSCLC, with the potential to create a curable future for more patients.

Statistics:

  • Approximately 2.48 million new cases of lung cancer occurred worldwide in 2022 [1].
  • NSCLC is the most common subtype of lung cancer, accounting for approximately 85% of all cases [2].
  • Among patients with resectable NSCLC, 20-25% can be surgically resected at initial diagnosis, but 30-55% will still relapse and die after surgery [3, 4].
  • The study aims to recruit patients with stage II/III, resectable, AGA-negative NSCLC.

Sources:

[1] Chinese Guidelines for the Diagnosis and Treatment of Psoriasis (2018 full version), Chinese Journal of Dermatology, Volume 52, Issue 10, October 2019.

[2] Griffiths, CEM, et al., The global state of psoriasis disease epidemiology: a workshop report. Br J Dermatol, 2017. 177(1): p. e4-e7.

[3] International Federation of Psoriasis Associations. World Psoriasis Day 2015.

[4] Ding, et al. [6] Gerdes S, Mrowietz U. Comorbidities and psoriasis. Impact on clinical practice­». Hautarzt, 2012,63(3):202-213.

[5] Cohen BE, Martires KJ, Ho RS. Psoriasis and the Risk of Depression in the US Population: National Health and Nutrition Examination Survey 2009-2012. JAMA Dermatol. 2016; 152(1): 73-79.