Nivolumab for unresectable cutaneous epithelial malignancies: an open-label, single-arm, multi-centre, phase II trial (NMSC-PD1) - PubMed

4 hours ago

Nivolumab was tested in a phase II trial for Japanese patients with advanced non-melanoma skin cancers (NMSCs), including rare types like extramammary Paget's disease (EMPD) and adnexal carcinomas.
The study was open-label, single-arm, and multi-centre, involving 31 patients with a median age of 73 years, 71% of whom were male.
Nivolumab was administered at 480 mg every 4 weeks for up to 26 cycles, with the primary endpoint being overall response rate (ORR) assessed by blinded independent central review (BICR).
The ORR was 22.6%, with a disease control rate of 54.8%. Responses were durable, lasting a median of 21.3 months.
Tumour mutational burden (TMB) was lower in the cSCC cohort compared to Western series, with higher TMB correlating with better response rates.
Common adverse events included pyrexia, hypothyroidism, adrenal insufficiency, and pruritus.
The study concluded that nivolumab showed durable antitumour activity with manageable toxicity in Japanese patients with advanced NMSCs, though ORR was lower compared to Western trials, possibly due to biological differences.
The trial was registered as jRCT2031190048 and conducted in accordance with ethical guidelines, including the Declaration of Helsinki.

Hasty Briefsbeta