942P - Response to salvage chemotherapy with paclitaxel +/- cetuximab after progression on immune checkpoint inhibitors in platinum-refractory recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) patients (CeTax study)

Background

Immune checkpoint inhibitors (ICI) and platinum-based chemotherapy are the standard treatments of R/M SCCHN patients (pts). After progression on these therapies, there is a lack of data and no standard of care exists.

Methods

This is a multicentric retrospective study (3 French and 3 Swiss centers). We analyzed the efficacy and safety of paclitaxel alone (P) or in combination with the epidermal growth factor receptor (EGFR) monoclonal antibody cetuximab (PC) beyond ICI progression in platinum-refractory and taxane naïve R/M SCCHN pts treated from January 2016 to August 2022. Primary endpoint was objective response rate (ORR) according to RECIST 1.1 criteria.

Results

We included 152 pts treated with P (69 pts, 45%) or PC (83 pts, 55%): 73% were males, 81% smokers. Median age was 67 (24-86). The ORR was 45% in the total population (TP), 22.4% in P group and 63.5% in PC group (p<0.001). The disease control rate (DCR) was 68.5% in the TP, 56.7% in P group and 78.1% in PC group (p=0.007). The median overall survival was 8.0 months (m) [95% CI: 7.0-9.4] in the TP, 6.9 m [95% CI: 5.5-8.2] in the P group and 9.4 m [95% CI: 8.0-11.8] in the PC group (p=0.02). The median progression free survival was 4.0 m [95% CI: 3.3-4.7] in the TP, 2.8 m [95% CI: 2.5-3.7] in the P group and 4.9 m [95% CI: 4.3-5.7] in the PC group (p<0.001). The rate of G3/G4 adverse event (AE) was 18.8% in P group and 21.7% in PC group. One patient died of septic shock in PC group. The most common G3/G4 AE were neuropathy (8.6%) in P group and acneiform rash (10%) in PC group. Table: 942P

Response Rate according to type of treatment CR: Complete response; PR: Partial response; SD: Stable disease; PD: Progressive disease; NE: Not evaluable

Conclusions

Taxane-based chemotherapy is highly active and well-tolerated after ICI failure in platinum-refractory R/M SCCHN pts. Our results suggest a potential additional benefit of cetuximab combined with paclitaxel in this population and deserves further investigation in prospective randomized clinical trials.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

CHUV - Centre Hospitalier Universitaire Vaudois.

Funding

Has not received any funding.

Disclosure

E. Auclin: Financial Interests, Personal and Institutional, Advisory Board: Amgen, Sanofi. C. Gervais: Financial Interests, Personal, Invited Speaker: MSD, mundipharma, astellas, janssen. V.G. Espeli: Financial Interests, Institutional, Speaker, Consultant, Advisor: Merck-Serono, Merck Sharp&Dohme; Non-Financial Interests, Personal and Institutional, Other, Travel, Accommodations, Expenses: Sanofi. S.I. Rothschild: Financial Interests, Institutional, Speaker, Consultant, Advisor: AstraZeneca, Roche Pharma AG, Bristol Myers Squibb, Boehringer Ingelheim, MSD Oncology, Novartis, Amgen, Eli Lilly, Eisai, Merck Serono, Pfizer, Takeda, Bayer, Janssen Oncology, Otsuka, PharmaMar, Sanofi/Aventis; Financial Interests, Institutional, Research Funding: AbbVie, Bristol Myers Squibb, AstraZeneca, Boehringer Ingelheim, Merck Serono, Roche Pharma AG. C. Even: Financial Interests, Personal, Advisory Board: BMS, MSD, Innate Pharma, Merck Serono; Financial Interests, Institutional, Advisory Board: F Star Therapeutics, Novartis, Elevar; Financial Interests, Institutional, Local PI: BMS, AstraZeneca, ISA pharmaceutics, MSD, Debiopharma, Ayala, Gilead; Financial Interests, Institutional, Coordinating PI: BMS, Novartis, sanofi. V. Cristina: Financial Interests, Institutional, Speaker, Consultant, Advisor: Merck Sharp&Dohme, Merck-Serono; Financial Interests, Institutional, Invited Speaker: Eisai; Financial Interests, Institutional, Advisory Board: Eli Lilly, Servier; Financial Interests, Institutional, Local PI: Merck Sharp&Dohme, Merck-Serono, MaxiVAX. All other authors have declared no conflicts of interest.