April 12, 2024

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AstraZeneca’s $1.275 billion first-in-class therapy  fails first phase 3 study

AstraZeneca’s $1.275 billion first-in-class therapy  fails first phase 3 study


AstraZeneca’s $1.275 billion first-in-class therapy  fails first phase 3 study.

On August 1, AstraZeneca partner Innate Pharma SA announced that the planned interim analysis of the AstraZeneca-sponsored Phase 3 INTERLINK-1 study of Monalizumab did not meet a predetermined efficacy threshold.

Based on this result and the recommendation of an independent data monitoring committee, AstraZeneca has informed Innate that the study will be discontinued. AstraZeneca plans to share relevant data in due course.


The AstraZeneca-sponsored INTERLINK-1 study evaluated Monalizumab in combination with cetuximab vs. cetuximab in patients with prior platinum-based chemotherapy and PD-(L)1 inhibitors for relapse or metastasis Outcomes in patients with recurrent squamous cell carcinoma of the head and neck (R/MSCCHN).


Monalizumab is a potential first-in-class immune checkpoint inhibitor targeting the NKG2A receptor expressed on tumor-infiltrating cytotoxic CD8+ T cells and NK cells.


NKG2A is an inhibitory checkpoint receptor for HLA-E. By expressing HLA-E, cancer cells can protect themselves from NKG2A+ immune cells.

HLA-E is frequently overexpressed in cancer cells of many solid tumors and hematological malignancies.

Monalizumab may reconstitute broad antitumor responses mediated by NK and T cells and may enhance the cytotoxic potential of other therapeutic antibodies.


AstraZeneca's $1.275 billion first-in-class therapy  fails first phase 3 study

Figure Monalizumab mechanism of action


Innate CEO Mondher Mahjoubi said: “Following the promising signals observed in the non-randomized Phase 1b/2 study of Monalizumab in head and neck cancer, the Phase 3 INTERLINK-1 study is designed to further evaluate this new immunotherapy option.

We are disappointed with the results of this study, but these findings will certainly advance our understanding of the role of immunotherapy in this application.

We remain confident in the development program for Monalizumab in lung cancer following randomized, phase 2 COAST and Neo- The COAST study reported encouraging data.

Our focus on Monalizumab remains the phase 3 PACIFIC-9 study in the setting of unresectable stage III non-small cell lung cancer, and the phase 2 NeoCOAST- 2 studies.”


Susan Galbraith, executive vice president of oncology research and development at AstraZeneca, also said: “We will continue to explore the impact of Monalizumab in patients with non-small cell lung cancer in different trials, including the phase 3 PACIFIC-9 trial.”


A Phase 3 PACIFIC-9 clinical study sponsored by AstraZeneca is ongoing evaluating durvalumab (PD-L1) in combination with Monalizumab or AstraZeneca’s oleclumab (anti-CD73) following concurrent platinum-based chemoradiotherapy Patients with unprogressed and unresectable stage III non-small cell lung cancer (NSCLC). However, the recently launched Phase 3 PACIFIC-9 study is expected to be initially completed in 2026.


In addition to the PACIFIC-9 study, the Phase 2 NeoCOAST-2 study of Monalizumab in the early neoadjuvant indication for NSCLC is also underway.


In October 2018, AstraZeneca acquired full oncology rights to Monalizumab by exercising an option under a co-development and commercialization agreement initiated in 2015.


Financial terms of the agreement include a cash payment to Innate of up to $1.275 billion, including a $50 million payment arising from the administration of the first patient.


Affected by news of the failure of the Phase 3 study of Monalizumab , Innate ‘s shares fell 20% in early Paris trading on the same day. The company’s stock has fallen more than 40% so far this year.







AstraZeneca’s $1.275 billion first-in-class therapy  fails first phase 3 study

(source:internet, reference only)

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