Innate Pharma SA: Monalizumab Data From NeoCOAST-2 Phase 2 Study in Early-Stage NSCLC Presented at the WCLC 2024

Rhea-AI Summary

Innate Pharma SA announced interim results from AstraZeneca's NeoCOAST-2 Phase 2 study presented at the 2024 World Conference on Lung Cancer. The study evaluates neoadjuvant durvalumab alone or combined with novel agents and chemotherapy in resectable, early-stage non-small cell lung cancer (NSCLC). Preliminary data from Arm 2 showed that monalizumab added to durvalumab plus platinum-based chemotherapy induced a pathological complete response rate of 26.7% and a major pathological response rate of 53.3%, numerically higher than the approved regimen. The treatment demonstrated a manageable safety profile with no impact on surgical rate. Innate Pharma's Chief Medical Officer expressed excitement about the potential of extending durvalumab's clinical benefit with monalizumab in NSCLC patients.

Positive

• Monalizumab combined with durvalumab and chemotherapy showed higher response rates than the approved regimen
• Treatment demonstrated a manageable safety profile
• No impact on surgical rate observed
• Potential to extend clinical benefit of durvalumab in neoadjuvant/adjuvant setting for NSCLC patients

Negative

• None.

Oncology Researcher

The NeoCOAST-2 Phase 2 study results for monalizumab in early-stage NSCLC are promising. The 26.7% pathological complete response rate and 53.3% major pathological response rate are numerically higher than the approved durvalumab plus platinum doublet regimen. This suggests potential enhanced efficacy when adding monalizumab to the standard treatment.

Monalizumab's unique mechanism as an NKG2A checkpoint inhibitor targeting both NK and CD8 T cells could explain these improved outcomes. The manageable safety profile and lack of impact on surgical rates are also encouraging, indicating that this combination might be well-tolerated in the neoadjuvant setting.

However, it's important to await the final analysis and, more importantly, the Event Free Survival (EFS) data to fully assess the clinical benefit. These preliminary results warrant further investigation but should be interpreted cautiously until more robust, long-term data are available.

Financial Analyst

For Innate Pharma, these preliminary results from the NeoCOAST-2 study are potentially significant. The numerically higher response rates for monalizumab in combination with durvalumab and chemotherapy could position this drug as a valuable addition to the current standard of care in early-stage NSCLC.

If further validated, this could represent a substantial market opportunity. The NSCLC market is projected to reach $43.3 billion by 2029 and gaining a foothold in the early-stage treatment landscape could be lucrative. However, investors should note that these are interim results from a Phase 2 study and the path to potential approval and commercialization is still long.

The partnership with AstraZeneca adds credibility and resources to the development process, which is a positive factor for Innate Pharma's prospects. Nonetheless, the company's financial performance will depend on the final study results and subsequent regulatory decisions.

Medical Research Analyst

The NeoCOAST-2 study's preliminary results for monalizumab are intriguing from a research perspective. The 26.7% pathological complete response rate and 53.3% major pathological response rate in the neoadjuvant setting are promising indicators of potential efficacy. These outcomes suggest that targeting NKG2A on both NK cells and CD8 T cells might enhance the anti-tumor immune response in early-stage NSCLC.

However, it's important to consider the study's limitations. With only 60 out of 72 patients analyzed, the sample size is relatively small. The confidence intervals are quite wide, indicating a degree of uncertainty in these results. Moreover, the lack of direct comparison to a control arm in this presentation makes it challenging to draw definitive conclusions about superiority over the current standard of care.

The upcoming Event Free Survival (EFS) data will be critical in determining the true clinical benefit of this combination. Researchers should also focus on identifying biomarkers that could predict which patients are most likely to benefit from this approach, potentially leading to more personalized treatment strategies in early-stage NSCLC.

MARSEILLE, France--(BUSINESS WIRE)-- Regulatory News:

Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that AstraZeneca (LSE/STO/Nasdaq: AZN) presented interim results from the randomized NeoCOAST-2 (NCT05061550) Phase 2 platform study during the 2024 World Conference on Lung Cancer on September 8, 2024.

The NeoCOAST-2 platform study is intended to assess the safety and efficacy of neoadjuvant durvalumab alone or combined with novel agents and chemotherapy in resectable, early-stage non-small cell lung cancer (NSCLC), followed by adjuvant treatment with durvalumab with or without the novel agents. The preliminary data of three arms were presented at WCLC, namely:

• Arm 1: oleclumab in combination with durvalumab and platinum doublet chemotherapy in the neoadjuvant setting and durvalumab plus oleclumab in the adjuvant setting;
• Arm 2: monalizumab in combination with durvalumab and platinum doublet chemotherapy in the neoadjuvant setting and durvalumab plus monalizumab in the adjuvant setting and;
• Arm 4: datopotamab deruxtecan in combination with durvalumab and single agent platinum chemotherapy in the neoadjuvant setting, and durvalumab alone in the adjuvant setting.

In this preliminary analysis on the first 60 of 72 patients randomized to Arm 2, monalizumab added to durvalumab plus platinum-based chemotherapy doublet induced a pathological complete response rate of 26.7% [95% CI; 16.1–39.7] and a major pathological response rate of 53.3% [95% CI; 40.0–66.3] which are numerically higher than the durvalumab plus platinum doublet approved regimen. Treatment in Arm 2 showed manageable safety profile and no impact on surgical rate.

The presentation will be available on Innate’s website, in the publications section.

“We’re pleased to see the preliminary results from the NeoCOAST-2 Phase 2 trial presented at WCLC and the encouraging clinical outcomes for patients with early-stage non-small cell lung cancer across all treatment arms,” said Dr Sonia Quaratino, Chief Medical Officer of Innate Pharma. “Monalizumab is the first checkpoint inhibitor targeting the inhibitory receptor NKG2A on NK cells and CD8 T cells. Based on these preliminary results, we remain excited about the potential of extending the clinical benefit of durvalumab in the neoadjuvant/adjuvant setting with the addition of monalizumab in patients with non-small cell lung cancer. We look forward to the final analysis and the translation of these preliminary data to Event Free Survival (EFS) data in due course.”

About NSCLC:

In 2022, an estimated 2.5 million people were diagnosed with lung cancer worldwide¹. Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% classified as NSCLC^2,3,4 Stage III NSCLC represents approximately one quarter of NSCLC incidence⁵.

Stage III (locally advanced) NSCLC is commonly divided into three subcategories (IIIA, IIIB and IIIC), defined by how much the cancer has spread locally.

About Monalizumab

Monalizumab is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors 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 killing by NKG2A+ immune cells. HLA-E is frequently overexpressed in the cancer cells of many solid tumors and hematological malignancies. Monalizumab may reestablish a broad anti-tumor response mediated by NK and T cells and may enhance the cytotoxic potential of other therapeutic antibodies⁶.

AstraZeneca obtained full oncology rights to monalizumab in October 2018 through a co-development and commercialization agreement initiated in 2015. The ongoing development for monalizumab is focused on investigating monalizumab in various combination strategies in NSCLC and other malignancies.

About Innate Pharma

Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Its innovative approach aims to harness the innate immune system through therapeutic antibodies and its ANKET^® (Antibody-based NK cell Engager Therapeutics) proprietary platform.

Innate’s portfolio includes lead proprietary program lacutamab, developed in advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas, monalizumab developed with AstraZeneca in non-small cell lung cancer, as well as ANKET^® multi-specific NK cell engagers to address multiple tumor types.

Innate Pharma is a trusted partner to biopharmaceutical companies such as Sanofi and AstraZeneca, as well as leading research institutions, to accelerate innovation, research and development for the benefit of patients.

Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US.

Learn more about Innate Pharma at www.innate-pharma.com and follow us on LinkedIn and X.

Information about Innate Pharma shares

ISIN code Ticker code LEI

FR0010331421 Euronext: IPH Nasdaq: IPHA 9695002Y8420ZB8HJE29

Disclaimer on forward-looking information and risk factors

This press release contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including “believe,” “potential,” “expect” and “will” and similar expressions, is intended to identify forward-looking statements. Although the company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, progression of and results from its ongoing and planned clinical trials and preclinical studies, review and approvals by regulatory authorities of its product candidates, the Company’s commercialization efforts and the Company’s continued ability to raise capital to fund its development. For an additional discussion of risks and uncertainties which could cause the company's actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque") section of the Universal Registration Document filed with the French Financial Markets Authority (“AMF”), which is available on the AMF website (http://www.amf-france.org) or on Innate Pharma’s website (www.innate-pharma.com), and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 20-F for the year ended December 31, 2023, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public, by the Company.

This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country.

¹ Ferlay J, Ervik M, Lam F, Laversanne M, Colombet M, Mery L, Piñeros M, Znaor A, Soerjomataram I, Bray F (2024). Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer. Available from: https://gco.iarc.who.int/today

² Provencio M, et al. Inoperable Stage III Non-Small Cell Lung Cancer: Current Treatment and Role Of Vinorelbine. J Thorac Dis. 2011;3:197-204

³ Cheema PK, et al. Perspectives on Treatment Advances for Stage III Locally Advanced Unresectable Non-Small-Cell Lung Cancer. Curr Oncol. 2019;26(1):37–42.

⁴ LUNGevity Foundation. Types of Lung Cancer. Available at https://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer. Accessed September 2021.

⁵ EpiCast Report: NSCLC Epidemiology Forecast to 2025. GlobalData. 2016.

⁶ André et al, Cell 2018

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For additional information, please contact:



Investors

 

Innate Pharma  

Henry Wheeler

Tel.: +33 (0)4 84 90 32 88

Henry.wheeler@innate-pharma.fr

 

Media Relations

 

NewCap

Arthur Rouillé

Tel.: +33 (0)1 44 71 00 15

innate@newcap.eu

Source: Innate Pharma SA

FAQ

What were the key findings of the NeoCOAST-2 Phase 2 study for IPHA's monalizumab?

The study showed that monalizumab combined with durvalumab and platinum-based chemotherapy induced a pathological complete response rate of 26.7% and a major pathological response rate of 53.3% in early-stage NSCLC patients, which were numerically higher than the approved regimen.

How did the safety profile of monalizumab in the NeoCOAST-2 study affect IPHA's stock outlook?

The treatment showed a manageable safety profile with no impact on surgical rate, which is potentially positive for IPHA's stock outlook as it suggests the drug could be well-tolerated in early-stage NSCLC patients.

What is the significance of monalizumab's mechanism of action for IPHA in the NSCLC market?

Monalizumab is the first checkpoint inhibitor targeting the inhibitory receptor NKG2A on NK cells and CD8 T cells, which could potentially extend the clinical benefit of durvalumab in the neoadjuvant/adjuvant setting for NSCLC patients, representing a unique market position for IPHA.

When will the final analysis of the NeoCOAST-2 study be available for IPHA's monalizumab?

The press release does not specify an exact date for the final analysis, but mentions that Event Free Survival (EFS) data will be available 'in due course'.