On October 23, 2020 Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) ("Innate" or the "Company") reported that AstraZeneca (LSE/STO/Nasdaq: AZN) has dosed the first patient in its Phase 3 clinical trial, INTERLINK-1, evaluating monalizumab in combination with cetuximab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) who have been previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors ("IO-pretreated") (Press release, Innate Pharma, OCT 23, 2020, View Source [SID1234568899]). 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.
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Dosing of the first patient in this trial has triggered a $50 million milestone payment from AstraZeneca to Innate.
"We are very pleased that our key late-stage asset, monalizumab, has progressed into Phase 3 with our partner, AstraZeneca. The launch of INTERLINK-1 represents an important financial milestone for Innate, as it triggers a $50 million milestone payment that fortifies our cash position through the end of 2022," said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "The steady and rapid progress of this program is a testament to our strong collaboration with AstraZeneca, and we are hopeful that together we will bring a novel treatment option to this patient population with high unmet medical need."
"Patients with head and neck cancer previously treated with a checkpoint inhibitor are a newly-defined patient population that is currently underserved. We look forward to evaluating the novel combination of monalizumab and cetuximab in the Phase 3 INTERLINK-1 study," said Cristian Massacesi, Senior Vice President, Head of Late Development Oncology R&D, AstraZeneca.
Presented at the ESMO (Free ESMO Whitepaper) 2019 Congress, the combination of monalizumab and cetuximab demonstrated a manageable safety profile and a response rate of 27.5% (36% and 17% in IO-naïve, n=22, and IO-pretreated patients, n=18, respectively). Based on these Phase 1b/2 results and the unmet need in the IO-pretreated population, AstraZeneca and Innate elected to advance this program directly to a Phase 3 study.
During the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program, Innate presented preliminary data from its Phase 2 expansion cohort evaluating monalizumab and cetuximab in IO-pretreated patients (cohort 2), which confirmed an overall response rate (ORR) of 20% across 40 patients enrolled. Overall, the combination therapy data to date supports the expedited development of monalizumab and cetuximab in this indication. Innate intends to provide an update on this data at an upcoming scientific meeting.
About INTERLINK-1:
INTERLINK-1 is a global, multi-center, randomized, double-blind Phase 3 study of monalizumab and cetuximab vs. placebo and cetuximab that will enroll approximately 600 patients with recurrent or metastatic head and neck squamous cell carcinoma of the head and neck (R/M SCCHN) who have been previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors ("IO-pretreated").
The primary endpoint is overall survival (OS) with secondary endpoints including progression-free survival (PFS), ORR, duration of response (DoR), safety and quality of life. Additional details on the INTERLINK-1 clinical trial can be found here.
About the Innate-AstraZeneca monalizumab agreement:
On April 24, 2015, the Company signed a co development and commercialization agreement with AstraZeneca to accelerate and broaden the development of monalizumab.
The financial terms of the agreement include potential cash payments up to $1.275 billion to Innate Pharma. Including the $50 million payment triggered by dosing the first patient in the Phase 3 INTERLINK-1 clinical trial, Innate Pharma has received $400 million to date.
AstraZeneca will book all sales revenue and will pay Innate low double-digit to mid-teen percentage royalties on net sales worldwide except in Europe where Innate Pharma will receive 50% share of the profits and losses in the territory. Innate will co-fund 30% of the costs of the Phase 3 development program of monalizumab with a pre-agreed limitation of Innate’s financial commitment.