FDA Approval Insights: Toripalimab in Recurrent/Metastatic Nasopharyngeal Carcinoma

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Drs Hanna and Kandula discuss the significance of the FDA approval of toripalimab in nasopharyngeal carcinoma; pivotal data from the JUPITER-02 and POLARIS-02 trials; and how this regulatory decision increases the importance of multidisciplinary collaboration.

Welcome to OncLive On Air®! I’m your host today, Ashling Wahner.

OncLive On Air is a podcast from OncLive®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, sponsored by Coherus, we had the pleasure of speaking with Glenn J. Hanna, MD, and Shravan Kandula, MD, about the FDA approval of toripalimab (Loqtorzi) in patients with recurrent or metastatic nasopharyngeal carcinoma. Dr Hanna is the director of the Center for Cancer Therapeutic Innovation (Early Drug Development Program), the director of the Center for Salivary and Rare Head and Neck Cancers, and a physician at Dana-Farber Cancer Institute, as well as an assistant professor of medicine at Harvard Medical School, both in Boston, Massachusetts. Dr Kandula is a radiation oncologist at AdventHealth Medical Group Radiation Oncology at Central Florida in Orlando.

On October 27, 2023, frontline toripalimab plus gemcitabine and cisplatin received FDA approval for adult patients with recurrent or metastatic locally advanced nasopharyngeal cancer. The FDA also approved toripalimab monotherapy for adult patients with recurrent or metastatic nasopharyngeal carcinoma whose disease progressed on or after platinum-based chemotherapy. These regulatory decisions were supported by findings from the phase 3 JUPITER-02 (NCT03581786) and phase 1/2 POLARIS-02 (NCT02915432) trials, respectively.

In JUPITER-02, toripalimab in combination with chemotherapy reduced the risk of disease progression or death by 48% vs chemotherapy alone. In POLARIS-02, toripalimab monotherapy elicited an overall response rate of 20.5%.

In our exclusive interview, Drs Hanna and Kandula discussed the significance of this approval; pivotal data from the JUPITER-02 and POLARIS-02 trials; and how the addition of toripalimab to the nasopharyngeal carcinoma treatment armamentarium increases the importance of multidisciplinary collaboration.

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