drugset / Press release

Monalizumab combined with cetuximab and durvalumab demonstrates anti-tumor activity in first-line recurrent or metastatic head and neck cancer at ESMO Immuno-Oncology 2021 Congress

2021-12-09 · Innate Pharma · original innate-pharma.com ↗

First chemo-free triplet shows preliminary activity and an acceptable safety profile with low rate of discontinuation Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“ Innate ” or the “ Company ”) today announced that data from the Phase 2 expansion cohort (‘cohort 3’), exploring the triplet combination of monalizumab, cetuximab and durvalumab in the first-line treatment of patients with recurrent or metastatic head and neck squamous cell cancer (R/M HNSCC), will be presented virtually today at the ESMO Immuno-Oncology Congress 2021. Monalizumab, Innate’s lead partnered asset, is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor-infiltrating cytotoxic CD8+ T cells and NK cells. “ These data show anti-tumor activity in the first study to evaluate this chemo-free triplet combination in first-line recurrent or metastatic head and neck cancer, ” said Joyson Karakunnel, M.D., MSc, FACP, Chief Medical Officer of Innate Pharma . “ We believe that the combination of monalizumab with the other two antibodies has the potential to become a new treatment option for patients. We look forward to collaborating with AstraZeneca on next steps of this program .” Key Data Highlights After a median follow-up of 16.3 months, preliminary data suggest anti-tumor activity in the triplet of monalizumab, cetuximab and durvalumab in first-line treatment of R/M HNSCC. As of August 1, 2021, 40 patients were enrolled. Thirteen patients had a confirmed response with a 32.5% overall response rate (95% confidence interval (CI): 20-48), including three complete responses. Seven out of 13 responders were still on treatment. Median duration of response was not yet reached (95% CI: 7.1-not available). The survival rate at 12 months was 58.6% (95% CI: 45-77) and the median overall survival was 15 months (95% CI: 11.4 - not available). In addition, Innate performed an exploratory subgroup analyses (n=40) according to Combined Positive Score (CPS), which is a PD-L1 scoring method that helps predict response to anti-PD-(L)1 therapy. In this analysis, CPS>1 (n = 25), the subset that had the greatest number of patients, showed a 40% overall response rate (95% CI: 23-59) and median overall survival of 17.3 months (95% CI: 14.7-NA). There were 5 patients with CPS<1, and CPS was unavailable for 10 patients. The safety of this chemotherapy free regimen was acceptable with a low rate of discontinuation. Presentation Details The oral presentation (#123MO) entitled, “Monalizumab, cetuximab and durvalumab in first-line treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN): a phase 2 trial,” will be presented from 12:15-12:20 pm CET today. Subscribe to our newsletter Contact us 117, Avenue de Luminy - BP 30191 13 009 Marseille FRANCE +33 (0)4 30 30 30 30

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