KEY TAKEAWAYS
- The MATISSE phase II trial evaluated the efficacy of neoadjuvant NIVO and NIVO+COMBO in CSCC with extensive surgery indication.
- The primary objective was the pathological response at surgery, residual viable cancer cells. Secondary endpoints included tolerability (CTCAE v.5.0), survival, and QOL.
- Results demonstrated that 50 pts with advanced CSCC were treated with neoadjuvant immunotherapy.
The MATISSE phase II trial evaluated the efficacy of neoadjuvant nivolumab (NIVO) and nivolumab plus ipilimumab (COMBO) in care for locally advanced cutaneous SCC (CSCC) with extensive surgery indication.
The study included 40 CSCC patients (pts) (T1-4N0-3M0 or TxN1-3M0) with indications for extensive and/or mutilating surgery. They were randomized into ARM A: NIVO (3 mg/kg, weeks 0&2, N = 26) or ARM B: NIVO (3 mg/kg, weeks 0&2) + IPI (1 mg/kg, week 0, N = 24) before surgery (week 4). The primary objective was the pathological response at surgery, defined as ≤10% residual viable cancer cells. Secondary endpoints included tolerability (CTCAE v.5.0), survival, and quality of life (QOL). The trial also investigated the immunogenomic features related to immunotherapy response through pre- and on-treatment tumor sample collection.
The results showed that of 50 enrolled pts, median age 76, 32% had TxN1-3M0 disease. Grade 3-4 irAEs occurred in 6 (12%) pts but were well manageable. Out of 40 pts who underwent standard surgery with or without adjuvant radiotherapy (RT), 40% achieved a major pathological response (MPR) with NIVO, and 53% with COMBO. Ten pts withdrew consent for surgery and RT, with 9 of them reporting significant clinical remission after neoadjuvant immunotherapy, confirmed by FDG-PET evaluation in week 4. These 9 pts remained cancer-free after a median follow-up of 12 months (range 4 to 27) and have better QoL compared to those receiving standard care. Overall, 13/26 (50%) and 14/23 (61%) of pts showed deep clinical responses with NIVO and COMBO, respectively, either as an MPR at surgery or a clinical CR in those declining surgery.
The study concluded that noticeable responses of 50% and 61%, accompanied by manageable side effects, were observed in elderly CSCC patients undergoing neoadjuvant treatment with NIVO and COMBO.
Source: https://meetings.asco.org/abstracts-presentations/218503
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT04620200
Charlotte L. Zuur, Sabine Breukers, Mercedes Machuca-Ostos, Thomas Boere, Laura Smit, J.P. De Boer, Sten Cornelissen, Arash Navran, Winan J. van Houdt, Bram Westerink, Maurits Wondergem, Remco de Bree, Lot A. Devriese, Daniela Thommen, Joleen Traets, and John B. A. G. Haanen. Journal of Clinical Oncology (2023).
