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Proffered Paper session - Head and neck cancer, excl. thyroid

LBA35 - Avelumab-cetuximab-radiotherapy versus standards of care in patients with locally advanced squamous cell carcinoma of head and neck (LA-SCCHN): Randomized phase III GORTEC-REACH trial

Date

20 Sep 2021

Session

Proffered Paper session - Head and neck cancer, excl. thyroid

Presenters

Jean Bourhis

Citation

Annals of Oncology (2021) 32 (suppl_5): S1283-S1346. 10.1016/annonc/annonc741

Authors

J. Bourhis1, Y. Tao2, X. Sun3, C. Sire4, L. Martin5, X. Liem6, A. Coutte7, Y. Pointreau8, J. Thariat9, J. Miroir10, F. Rolland11, M. Kaminsky12, C. Borel13, A. Maillard2, L. Sinigaglia14, J. Guigay15, E. Saada-Bouzid9, C. Even16, A. Aupérin17

Author affiliations

  • 1 Radiation Oncology Department, CHUV - Centre Hospitalier Universitaire Vaudois, 1011 - Lausanne/CH
  • 2 Radiation Oncology, Institut Gustave Roussy, 94805 - Villejuif/FR
  • 3 Franche-comte, Hôpital Nord Franche-Comté - HNFC, 90015 - Belfort/FR
  • 4 Lorient, Centre Hospitalier de Bretagne Sud – Site du Scorff, 56322 - Lorient/FR
  • 5 Le Havre, Clinique des Ormeaux, 76600 - Le Havre/FR
  • 6 Lille, Centre Oscar Lambret, 59000 - Lille/FR
  • 7 Oncology Radiotherapy Department, CHU Amiens-Picardie - Site Sud, 80054 - Amiens/FR
  • 8 Le Mans, Centre Jean Bernard, 72000 - Le Mans/FR
  • 9 Nice, Centre Antoine Lacassagne, 06100 - Nice/FR
  • 10 Clermont-ferrand, Centre Jean Perrin, 63011 - Clermont-Ferrand/FR
  • 11 Medical Oncology Department, ICO Institut de Cancerologie de l'Ouest René Gauducheau, 44805 - Saint-Herblain/FR
  • 12 Lorraine, Institut de Cancérologie de Lorraine, 54519 - Vandoeuvre-les-Nancy/FR
  • 13 Strasbourg, Centre Paul Strauss Centre de Lutte contre le Cancer, 67065 - Strasbourg/FR
  • 14 Tours, GORTEC, 37000 - Tours/FR
  • 15 Medical Oncology Department, Centre Anticancer Antoine Lacassagne, 06189 - Nice/FR
  • 16 Head And Neck Department, Gustave Roussy, 94805 - Villejuif/FR
  • 17 Head And Neck Cancer, Institut Gustave Roussy, 94805 - Villejuif/FR
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Resources

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Abstract LBA35

Background

Based on a potential synergistic effect of anti–PD-L1 avelumab plus cetuximab and radiotherapy (RT), this combination was tested in a randomized phase III trial against 2 standards of care (SOC) in LA-SCCHN.

Methods

The trial comprised 2 cohorts of patients (pts) fit for cisplatin (3 cycles of 100 mg/m2, Q3W) or unfit for cisplatin. The SOC was IMRT 70 Gy / 6.5 weeks with cisplatin in fit pts and with cetuximab in unfit pts (Bonner, 2006). In both cohorts, experimental arm (Exp) was 70 Gy / 6.5 weeks plus weekly cetuximab and avelumab 10 mg/kg at Day-7 and every 2 weeks during RT followed by avelumab for 12 months. The primary endpoint was progression-free survival (PFS). In Unfit pts, 115 events were needed / 277 pts to detect a HR of 0.62 (1-sided 0.05 type I error; power 80%). In Fit pts, 166 events were needed / 430 pts to detect a HR of 0.64 (2-sided 0.05 type I error; power 80%).

Results

Between 2017 and 2020, 707 pts were randomized. For cisplatin unfit pts , out of 277 pts, the number of PFS events was reached. Median age 67 years, 88% smokers, 61% oropharyngeal tumors (35% p16+), 24% stage III, 76% stage IV. Grade >= 3 AEs were 80% in both arms (p=0.91). Median follow-up was 21 months (IQR 15-28). PFS rate at 2 years (95%CI) was 44% (35%-53%) in Exp vs 31% (23%-40%) in Cetux-SOC (HR 0.85; p=0.15). Loco-regional progression at 2 years (95%CI) was 34% (26%-43%) in Exp vs 44% (35%-53%) in Cetux-SOC (HR = 0.83; p=0.34). Distant metastasis rate was lower in Exp (HR = 0.31, p=0.007). The 2-year OS rate (95%CI) was 58% (48%-67%) in Exp vs 54% in SOC (44%-64%) (HR 1.08; p-=0.69). For cisplatin fit pts, out of 430 pts, the number of PFS events was not reached. The interim analysis for futility based on 89 events in 317 first pts showed a 1-year PFS rate (95%CI) of 64% (54%-72%) in Exp vs 73% in SOC-cisplatin (65%-81%): HR 1.27 (95%CI 0.83-1.93), crossing the futility boundary.

Conclusions

In cisplatin-Unfit pts, a favorable effect of adding avelumab to cetuximab was seen on PFS, local-regional control, distant metastases, but the primary endpoint on PFS was not met. In cisplatin-Fit pts, the futility boundary for efficacy was crossed, favoring SOC cisplatin.

Clinical trial identification

NCT02999087.

Editorial acknowledgement

Legal entity responsible for the study

GORTEC.

Funding

GORTEC with a funding from MERCK Serono. This research was financially supported by Merck Serono S.A.S., Lyon, France, an affiliate of Merck KGaA, as part of an alliance between Merck (CrossRef Funder ID: 10.13039/100009945) and Pfizer.

Disclosure

All authors have declared no conflicts of interest.

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