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e-Poster Display Session

81P - Monalizumab in combination with cetuximab post platinum and anti-PD-(L)1 in patients with recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN): Updated results from a phase II trial

Date

09 Dec 2020

Session

e-Poster Display Session

Topics

Tumour Site

Head and Neck Cancers

Presenters

Jérome Fayette

Citation

Annals of Oncology (2020) 31 (suppl_7): S1441-S1451. 10.1016/annonc/annonc392

Authors

J. Fayette1, J. Bauman2, S. Salas3, D. Colevas4, C. Even5

Author affiliations

  • 1 Centre Léon Bérard, Lyon/FR
  • 2 Fox Chase Cancer Center, Philadelphia/US
  • 3 AP-HM, Marseille/FR
  • 4 Stanford University School of Medicine, Stanford/US
  • 5 Institut Gustave Roussy, Villejuif/FR
More

Abstract 81P

Background

Monalizumab is an immune checkpoint inhibitor targeting Natural Killer Group 2A (NKG2A) receptor, which is expressed on subsets of Natural Killer (NK) and CD8+T cells. NKG2A blockade promotes anti-tumor immunity and enhances NK cell antibody-dependent cell-mediated cytotoxicity by cetuximab. We previously reported the preliminary clinical activity and safety of monalizumab in combination with cetuximab in R/M SCCHN. To date, no treatment options are currently approved or showed substantial clinical activity in patients progressing following platinum and anti-PD-(L)1.

Methods

This is an international multi-cohort, non-randomized phase-I/II trial (NCT02643550). Eligible patients had R/M SCCHN previously treated with platinum ± anti-PD-(L)1 (Cohort 1) or platinum and anti-PD-(L)1 (Cohort 2) with 40 patients planned in each cohort. All patients received monalizumab intravenously 750 mg every two weeks along with standard dosing of cetuximab until progression or unacceptable toxicity. The primary endpoint is Overall Response Rate (ORR) assessed per RECIST 1.1. Main secondary endpoints include safety, Progression-Free Survival (PFS) and Overall Survival (OS). Here we present updated analysis for Cohort 2 and an exploratory analysis of all patients treated with platinum and anti-PD-(L)1 in both cohorts.

Results

As of August 31, 2020, 59 patients with R/M SCCHN post platinum and anti-PD-(L)1 were included, 19 in cohort 1, and 40 in cohort 2. The table shows the main efficacy endpoints for Cohort 2 and the exploratory analysis of both cohorts. Table: 81P

Cohort 2 N=40 All post platinum and anti-PD-(L)1 patients (Cohort 1+2) N=59
Median follow-up, months (range) 13.1 (7.9-15.9) 14.6 (7.9-28.4)
ORR, % [95%CI] 20% [11-35] 18.6% [11-30]
Median Time to Response, months [95%CI] 1.6 [1.6-5.3] 1.6 [1.6-5.3]
Median Duration of Response, months [95%CI] 5.2 [3.9-not reached] 5.6 [3.9-not reached]
Median PFS, months [95%CI] 3.4 [1.8-5.3] 3.5 [2.7-5.3]
Median OS, months [95%CI] 8.3 [7.3-12.4] 10.1 [8-16.5]
6 months OS, % [95%CI] 80% [69-93] 81% [72-92]

Conclusions

The monalizumab and cetuximab combination therapy shows promising activity in R/M SCCHN post platinum and anti-PD-(L)1. Based on these results, a randomized phase III trial is underway comparing the combination to cetuximab alone in this setting.

Clinical trial identification

NCT02643550; Release date: December 31, 2015.

Legal entity responsible for the study

Innate Pharma.

Funding

Innate Pharma and AstraZeneca.

Disclosure

J. Fayette: Honoraria (self): Innate Pharma; Honoraria (self), Research grant/Funding (institution), Non-remunerated activity/ies: AstraZeneca; Honoraria (self), Research grant/Funding (institution), Non-remunerated activity/ies: BMS; Honoraria (self), Non-remunerated activity/ies: MSD; Honoraria (self): Merck. J. Bauman: Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Kura Oncology; Advisory/Consultancy: Bayer; Research grant/Funding (institution): BMS. S. Messouak: Full/Part-time employment: Innate Pharma. S.L. Cornen: Full/Part-time employment: Innate Pharma. P. Andre: Full/Part-time employment: Innate Pharma. F. Rotolo: Full/Part-time employment: Innate Pharma. A. Boyer-Chammard: Full/Part-time employment: Innate Pharma. R.B. Cohen: Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Heat Biologics; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Innate Pharma; Advisory/Consultancy: Cantargia AB; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Genocea Biosciences; Advisory/Consultancy: Astrazeneca; Advisory/Consultancy, Research grant/Funding (institution): Xencor; Research grant/Funding (institution): Merck; Research grant/Funding (institution): Celldex; Research grant/Funding (institution): Kyntherapeutics. All other authors have declared no conflicts of interest.

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