Tam-Peli versus chemotherapy in heavily pretreated recurrent/metastatic nasopharyngeal carcinoma (R/M NPC): A multicenter, randomized, open-label, phase 3 study (TAISHAN-301)

TAISHAN-301

Patient / Population Intervention / Exposure Comparison Outcome

In heavily pretreated recurrent or metastatic nasopharyngeal carcinoma, tambotatug pelitecan improved confirmed objective response rate compared with physician's choice chemotherapy.

N

431patients

Design

Multicentre, randomised 1:1, open-label phase 3 trial in patients with recurrent or metastatic nasopharyngeal carcinoma previously treated with a PD-(L)1 inhibitor and at least 2 lines of chemotherapy including at least 1 platinum-based line, comparing the B7-H3-directed antibody-drug conjugate tambotatug pelitecan (Tam-Peli) with treatment of physician's choice (docetaxel, gemcitabine or capecitabine), stratified by ECOG PS and liver metastasis (NCT06629597).

Endpoint

Co-primary endpoints: objective response rate by blinded independent central review and overall survival. ORR was tested for superiority at a prespecified interim analysis.

ResultConfirmed ORR by BICR 50.8% with Tam-Peli vs 25.8% with treatment of physician's choice (OR 2.9, 95% CI 1.7-5.0; P<0.0001) at a median follow-up of 5.2 months. ORR benefit was consistent across subgroups, including liver metastasis (OR 4.3, 95% CI 2.0-9.2) and progression after more than 2 prior lines (OR 5.7, 95% CI 2.5-12.7). DCR 93.7% vs 75.8%. Median DoR 7.9 vs 6.4 months. OS and PFS were immature, with a favourable PFS trend. Grade 3 or higher treatment-related adverse events 49.3% vs 51.7%, most commonly neutropenia (27.0% vs 29.7%). No interstitial lung disease. One treatment-related death in each arm.

Hong SD, Ji D, Zhang P, et al. Presented at ESMO Congress 2026, abstract LBA43, 25 October. Not yet published.

Discussion & critique

At a prespecified interim analysis this trial shows that Tam-Peli roughly doubled the confirmed response rate compared with single-agent chemotherapy, and the response was assessed by blinded central review. Response rate is a surrogate, and with a median follow-up of only 5.2 months overall survival, the other co-primary endpoint, is immature. The abstract gives no PFS figures beyond a favourable trend. The trial is open label, rates of grade 3 or higher treatment-related toxicity were similar in both arms, and the study was funded by MediLink Therapeutics, which also employs several of the authors.