05Jun

Toripalimab in Combination with Gemcitabine and Cisplatin Demonstrates the Potential of Becoming a New Standard of Care

JUPITER-02 Phase-III study

Toripalimab is an anti-PD-1 monoclonal antibody that inhibits PD-L1 binding to the PD-1 receptor at a specific region, reducing the possibility for tumor cells to evade the immune system and decreases the PD-1 expression on T-cells as a secondary approach to restore the body's immune response. The FDA granted breakthrough therapy designations and priority review for toripalimab and also a Biologics License Application (BLA) for use in combination with gemcitabine and cisplatin as first-line treatment for patients with advanced recurrent or metastatic NPC, as well as for toripalimab monotherapy for recurrent or metastatic NPC after platinum-containing chemotherapy.

In the interim analysis of the JUPITER-02 trial, toripalimab in combination with GP chemotherapy demonstrated a substantial improvement in progression-free survival (PFS) as a first-line treatment for RM-Nasopharyngeal Carcinoma

In the JUPITER-02 study, 289 patients with advanced Nasopharyngeal Carcinoma who had not previously received chemotherapy were randomized (1:1) to receive toripalimab 240 mg (n=146) or placebo (n=143) every 3 weeks for up to 6 cycles, followed by monotherapy with toripalimab or placebo until disease progression, intolerable toxicity, or completion of two years of treatment. In the intention-to-treat population, the primary endpoint was PFS (progression free survival) by BIRC (blinded independent review committee). PFS by investigator, OS (overall survival), objective response rate (ORR), duration of response (DOR), and safety were all secondary endpoints.

The median overall survival follow-up period was 36 months in the final OS analysis. In the toripalimab arm, there was a substantial improvement in OS, but the median OS had not yet been attained, compared to 33.7 months in the placebo arm. The two-year and three-year OS rates for toripalimab along with chemotherapy versus placebo with chemotherapy were 78.0% vs. 65.1%, and 64.5% vs. 49.2%, respectively. Toripalimab outperformed the placebo by 13.2 months (21.2 months vs. 8.2 months) in the final PFS analysis.

KOL insights

“In comparison to chemotherapy alone, a combination comprising the immune checkpoint inhibitor toripalimab certainly has the potential to bring about extraordinary improvements in the extension of life in Nasopharyngeal Carcinoma patients.” -Expert Opinion.

“The primary endpoint result is outstanding, extending progression-free survival from 8.2 months with chemotherapy alone to 21.4 months with toripalimab, and now with the high overall survival results, this will be a new standard of care for patients if approved.”  -Expert Opinion.


 

Conclusion

Toripalimab added to GP chemotherapy as first-line treatment for advanced Nasopharyngeal Carcinoma had a tolerable safety profile and produced better PFS with a tendency towards improved overall survival compared to chemotherapy alone. 

The groundbreaking study shows that individuals with recurrent or metastatic nasopharyngeal cancer who were treated with toripalimab had a substantial survival benefit. No other PD-1 inhibitor presently on the market in the United States has completed a Phase III study in recurrent or metastatic Nasopharyngeal Carcinoma that met its main objectives. Toripalimab thus fills an essential unmet need for individuals with Nasopharyngeal Carcinoma who presently have no approved immunotherapies available in the United States