Hengrui's PD-1 Inhibitor Camrelizumab Nears Approval for Third-Line Treatment of Nasopharyngeal Carcinoma in China

On April 20, the official website of the National Medical Products Administration (NMPA) showed that the new indication application for Hengrui's Camrelizumab for Injection (registration category: 2.2; acceptance number: CXSS2000045) was in the "under review" status and is expected to be approved by NMPA soon.

The indication pending approval is for the treatment of patients with advanced nasopharyngeal carcinoma who have experienced disease progression or intolerance after receiving two or more prior lines of chemotherapy. Upon approval, this will mark the fifth approved indication for camrelizumab.

Indication Applications and Approval Status of Camrelizumab

At the 2020 ESMO Congress, Hengrui presented the results of the CAPTAIN study, a Phase II, multicenter, single-arm clinical trial evaluating camrelizumab monotherapy in patients with recurrent or metastatic nasopharyngeal carcinoma who had experienced disease progression after failure of two or more prior lines of therapy, including platinum-based regimens.

From August 14, 2018, to December 30, 2019, a total of 156 eligible patients received camrelizumab treatment. As of March 31, 2020, the median follow-up time for patients was 9.2 months (range: 0.7–19.1 months). Among the 156 patients, 44 (28.2%, 95% CI: 21.3–36.0) achieved an objective response assessed by IRC, including 1 complete response and 43 partial responses (PR). The median duration of response (DoR) was not reached (95% CI: 7.4–not estimable), with a 12-month DoR rate of 53.7% (95% CI: 30.9–72.0). The median overall survival (OS) was 17.1 months (95% CI: 15.2–not estimable).

Regarding safety, the incidence of treatment-related adverse events (TRAEs) of any grade was 96.8% (151/156), with the incidence of Grade ≥3 TRAEs being 14.1% (22 cases). The most common TRAEs included elevated glutamyl transferase (3.2%) and anemia (3.2%). Treatment was interrupted due to TRAEs in 18 patients, and one patient discontinued treatment.

Among the PD-1/L1 inhibitors currently approved in China, only Junshi Biosciences’ toripalimab and Hengrui Medicine’s camrelizumab have submitted marketing applications for the indication of nasopharyngeal carcinoma. The third-line treatment indication for toripalimab was approved by the NMPA on February 2 this year, while its first-line treatment indication has already been submitted for marketing approval. Hengrui’s third-line indication is expected to be approved soon, and its marketing application for the first-line indication was submitted earlier than that of Junshi, potentially leading to an earlier approval.

Furthermore, according to the PharmaCube NextClinTrial database, the pivotal Phase II clinical trial (AK105-202) of penpulimab, a PD-1 therapy developed by Chia Tai Tianqing and Akeso Biopharma, for third-line treatment of nasopharyngeal carcinoma has yielded positive results, with an objective response rate (ORR) of 27%. BeiGene’s clinical trial of tislelizumab as first-line treatment for nasopharyngeal carcinoma is ongoing, while Novartis is conducting a clinical trial of spartalizumab for second-line treatment of nasopharyngeal carcinoma.

In addition, Junshi Biosciences, Hengrui Medicine, and Innovent Biologics have each registered pivotal clinical trials evaluating PD-1 inhibitors in combination with chemoradiotherapy for high-risk patients with nasopharyngeal carcinoma. Junshi Biosciences has also registered a pivotal clinical trial of toripalimab as adjuvant therapy for nasopharyngeal carcinoma.