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Ivonescimab Monotherapy Demonstrates Statistically Significant Overall Survival Benefit Compared to Pembrolizumab Monotherapy in PD-L1-Positive Advanced NSCLC in HARMONi-2 Study Conducted by Akeso in China

Wednesday, September 2, 2026 BiopharmaWatch Research 1 min read
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Key Takeaway: Summit Therapeutics' partner Akeso has reported positive results from the Phase III HARMONi-2 study. The trial demonstrated that ivonescimab monotherapy significantly improves overall survival compared to pembrolizumab in patients with PD-L1-positive advanced non-small cell lung cancer. This finding could impact treatment strategies in this patient demographic.

Market Sentiment Analysis

POSITIVE FACTORS

  • Ivonescimab shows statistically significant overall survival benefit.
  • The study was conducted in a well-defined patient population.
  • Results may enhance treatment options for advanced NSCLC.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+1236%
120-day peak, hindsight
Typical move
47.7%
average across 2 past catalysts
Cash runway
~14 mo
Low dilution risk
Lead asset
Ivonescimab
Phase 3 · Non-Small Cell Lung Cancer

Full Press Release Details

MIAMI--(BUSINESS WIRE)---- $SMMT--Summit Therapeutics Inc. (NASDAQ: SMMT) today noted that its partner Akeso Inc. announced positive overall survival (OS) results from the randomized, double-blind Phase III HARMONi-2 study evaluating ivonescimab monotherapy against pembrolizumab monotherapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have positive PD-L1 expression. HARMONi-2 (AK112-303) is a single-region, multi-center Phase III study conducted in China

Frequently Asked Questions

What is the HARMONi-2 study about?

The HARMONi-2 study evaluates ivonescimab monotherapy against pembrolizumab in advanced NSCLC.

What were the results of the HARMONi-2 study?

The study showed that ivonescimab significantly improved overall survival compared to pembrolizumab.

Who conducted the HARMONi-2 study?

The study was conducted by Akeso Inc. in China.

What type of cancer was targeted in the study?

The study targeted locally advanced or metastatic non-small cell lung cancer.

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Tags: SMMT Viatris Investor Conferences Healthcare ivonescimab pembrolizumab NSCLC HARMONi-2 Akeso
Last updated: Sep 2, 2026

Biotech snapshot

Cash runway
$691M liquidity · $47M/mo burn
~14 mo
Low dilution risk
Lead asset
IvonescimabPhase 3
Non-Small Cell Lung Cancer →

Catalyst track record

+1236%
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