Toripalimab Yields ‘Striking’ PFS Improvement in Nasopharyngeal Carcinoma

“Solid” progression-free survival (PFS) and overall survival (OS) data with toripalimab-tpzi (Loqtorzi) support the role of PD-1 inhibition in the frontline treatment of those with recurrent or metastatic nasopharyngeal carcinoma (NPC), according to Barbara Burtness, MD.

In a conversation with CancerNetwork^®, Burtness, a professor of medicine at Yale School of Medicine and chief translational research officer and associate cancer center director for translational research at the Yale Cancer Center, spoke about how efficacy findings from the phase 3 JUPITER-02 study (NCT03581786) support the FDA approval of toripalimab in metastatic/recurrent NPC.¹

Transcript:

What has changed the standard of care is the JUPITER-02 trial,² where [289] patients were randomly assigned between the standard of care at that time, which was gemcitabine/cisplatin, or the same thing with the addition of toripalimab. When we first saw the data published in Nature Medicine in 2021,³ the primary end point of progression-free survival had gone through a prespecified interim analysis, and they already saw a significant improvement in progression-free survival from 8.0 [with placebo] to 11.7 months [with toripalimab] with a hazard ratio of 0.52.

At that point, the overall survival data were not yet mature. But we have now had an update of these data published in JAMA in November [2023]. Here we see with mature follow-up that the progression-free survival went from 8.2 months [with placebo] to 21.4 months [with toripalimab].² The overall survival, with a median follow-up of 3 years, had not been reached in the toripalimab group and was 33.7 months in the placebo group.

These data appear to be very solid. The control arm performed well, and there’s a striking improvement in progression-free survival and overall survival. It’s also supportive that a smaller randomized trial with an alternative PD-1 inhibitor had also been presented back in 2021, also showing a benefit. You have single-agent activity, you have 2 drugs in the class improving progression-free survival over chemotherapy, and now you have long-term overall survival data. It’s a very compelling story that PD-1 inhibition should be part of the first-line management of recurrent metastatic nasopharyngeal carcinoma.

References

1. Coherus and Junshi Biosciences announce FDA approval of LOQTORZI™ (toripalimab-tpzi) in all lines of treatment for recurrent or metastatic nasopharyngeal carcinoma (NPC). News release. Coherus Biosciences. October 27, 2023. Accessed January 17, 2024. http://tinyurl.com/4e8635a9
2. Mai HQ, Chen QY, Chen D, et al. Toripalimab plus chemotherapy for recurrent or metastatic nasopharyngeal carcinoma: the JUPITER-02 randomized clinical trial. JAMA. 2023;330(20):1961-1970. doi:10.1001/jama.2023.20181
3. Mai HQ, Chen QY, Chen D, et al. Toripalimab or placebo plus chemotherapy as first-line treatment in advanced nasopharyngeal carcinoma: a multicenter randomized phase 3 trial. Nature Med. 2021;27:1536-1543. doi10.1038/s41591-021-01444-0