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iTeos Therapeutics' Inupadenant Shows Promise in NSCLC Phase 2 Trial

• iTeos Therapeutics reported a 63.9% overall response rate (ORR) in a Phase 2 trial of inupadenant plus chemotherapy for metastatic non-small cell lung cancer (NSCLC). • The recommended Phase 2 dose (RP2D) of inupadenant (80mg) combined with carboplatin/pemetrexed showed a 73.3% ORR and 64.6% six-month progression-free survival (PFS). • Despite promising results, iTeos has decided to deprioritize inupadenant to focus on other programs, citing insufficient clinical activity to warrant further investment. • The safety profile of inupadenant combined with carboplatin/pemetrexed was manageable and tolerable, with no dose-dependent toxicities observed.

iTeos Therapeutics, Inc. (NASDAQ:ITOS) has announced interim data from its Phase 2 A2A-005 trial, evaluating inupadenant in combination with chemotherapy for patients with metastatic non-small cell lung cancer (NSCLC). The data, presented at the European Society for Medical Oncology Immuno-Oncology (ESMO IO) Congress 2024, revealed a 63.9% overall response rate (ORR) and a median progression-free survival (PFS) of 7.7 months across evaluable patients.
The trial's recommended Phase 2 dose (RP2D) of inupadenant, at 80mg combined with carboplatin/pemetrexed, demonstrated a 73.3% ORR. Furthermore, 64.6% of patients achieved a landmark 6-month PFS, indicating a substantial proportion of patients experienced sustained benefit.

Strategic Shift Despite Positive Data

Despite the encouraging results, iTeos Therapeutics has made the strategic decision to deprioritize inupadenant, redirecting resources to other programs within its pipeline. Michel Detheux, Ph.D., President and CEO of iTeos, explained that while the initial signals were promising, they did not meet the threshold of clinical activity required to justify further investment in the program.

Safety and Tolerability

The safety profile of inupadenant in combination with carboplatin/pemetrexed was reported as manageable and tolerable. The study found no dose-dependent toxicities, suggesting the combination is relatively well-tolerated in this patient population. The trial specifically included patients who had previously progressed on or after immune checkpoint inhibitor therapy, with a minimum follow-up period of six months.

Financial Considerations

iTeos Therapeutics maintains a strong balance sheet, possessing more cash than debt and a healthy current ratio of 14.8. However, InvestingPro data suggests the company is rapidly utilizing its cash reserves. This financial context likely influenced the decision to deprioritize inupadenant in favor of other clinical programs.

Broader Pipeline and Recent Developments

iTeos Therapeutics' pipeline includes three clinical-stage programs targeting novel immunosuppressive pathways. In other recent news, iTeos is making strides in its Phase 2 GALAXIES Lung-201 study, evaluating the combination of belrestotug and dostarlimab in treating PD-L1 high non-small cell lung cancer. Interim data from this study has demonstrated significant efficacy, drawing positive ratings from firms like JPMorgan, Piper Sandler, and H.C. Wainwright.
Additionally, iTeos recently announced a $120 million stock sale and reported a first-quarter net loss of $1.07 per share for 2024. The company also appointed Dr. David Feltquate as the new Chief Medical Officer and elected two Class I directors at its Annual Meeting of Stockholders.
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Reference News

[1]
Inupadenant shows promise in NSCLC Phase 2 trial results - Investing.com
investing.com · Dec 12, 2024

iTeos Therapeutics reported Phase 2 trial interim data for inupadenant in metastatic NSCLC, showing 63.9% ORR and 7.7 mo...

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