Toripalimab (Loqtorzi)

Key Messages

• Canada’s Drug Agency (CDA-AMC) recommends that Loqtorzi not be reimbursed by public drug plans for the treatment of adults with recurrent unresectable or metastatic nasopharyngeal carcinoma (NPC) with disease progression on or after a platinum-containing chemotherapy.
• The pan-Canadian Oncology Drug Review Expert Review Committee (pERC) concluded that Loqtorzi does not demonstrate acceptable clinical value compared with appropriate comparators such as chemotherapeutic agents in patients with previously treated NPC. Given that Loqtorzi is expected to be an alternative to chemotherapy, acceptable clinical value refers to at least comparable value versus drugs such as capecitabine, taxanes, or carboplatin that are currently used in Canada.
• The committee reviewed 1 phase II trial (POLARIS-02); however, this study did not compare Loqtorzi to any other drugs and therefore was not designed to demonstrate that treatment resulted in similar or better clinical benefit relative to any treatment. In this trial, patients treated with Loqtorzi had their cancer worsen within a median of 1.9 months and survived for a median of 15.7 months. Additionally, 20.9% of patients had their tumour shrink, a response that lasted a median of 14.9 months. Health-related quality of life (HRQoL), which is important to patients, was not assessed in the trial.
• The key limitation of the trial is that Loqtorzi was not compared to another drug, and this prevents any conclusion of the relative clinical value of Loqtorzi versus drugs usually prescribed to the target patient population. Additionally, no indirect treatment comparison was submitted to inform relative efficacy or safety of Loqtorzi compared to other drugs. In the absence of comparative evidence, the committee was unable to conclude that Loqtorzi provides clinical value for patients who have been previously treated.
• The committee considered whether the drug would address significant unmet clinical or nonclinical needs. The committee acknowledged needs for additional therapies in the context of an aggressive disease and broader needs for support of patients and caregivers, especially in underserved groups. However, the committee did not judge that Loqtorzi could address these needs with an acceptable level of certainty. Based on all the preceding considerations, pERC recommended that Loqtorzi not be reimbursed.