Onco-Summaries: Daily Oncology Updates at a Glance

24/04/2025

Ivonescimab Plus Chemotherapy Shows Statistically Significant Superiority Over Tislelizumab in First-Line Treatment of Squamous NSCLC (Ref 1)

Akeso and Summit Therapeutics' ivonescimab, a PD-1/VEGF bispecific antibody (BsAb), in combination with chemotherapy, met its primary endpoint of progression-free survival (PFS) in the Phase 3 HARMONi-6 trial versus tislelizumab (anti-PD-1) + chemotherapy as a first-line treatment of advanced, squamous non-small cell lung cancer (sq-NSCLC).

• Detailed results from the HARMONi-6 study will be presented at an upcoming medical conference later this year, potentially at ASCO 2025 Annual Meeting

• The BsAb regimen not only achieved a statistically significant improvement in the intention-to-treat population, but also demonstrated clinically meaningful PFS benefits in both PD-L1-positive and PD-L1-negative subgroups

• Ivonescimab demonstrated a favorable safety profile, with no new safety signals identified

• To note, the HARMONi-6 study has been sponsored by Akeso and enrolled patients at sites only in China

• Previously, ivonescimab also tasted success in first-line NSCLC with the Phase 3 HARMONi-2 trial, in which ivonescimab significantly improved PFS versus pembrolizumab in advanced, PD-L1 positive NSCLC patients

Nivolumab Plus Ipilimumab for Untreated Unresectable or Metastatic Colorectal Cancer with High MSI or dMMR (Ref 2)

The UK's NICE has recommended the use of Bristol Myers Squibb’s Opdivo (nivolumab; anti-PD-1) and Yervoy (ipilimumab; anti-CTLA-4) within its marketing authorisation, as a treatment option for adult, untreated, unresectable or metastatic colorectal cancer (CRC) patients with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR).

• Clinical data of nivolumab + ipilimumab versus chemotherapy from the Phase 3 CheckMate-8HW trial, and indirect comparison versus pembrolizumab suggested that the combination showed improved outcomes in these patients

• Additionally, the cost-effectiveness estimates of the combination were within the range that NICE considers an acceptable use of NHS resources, allowing for the recommendation

• To note, the combination can be used only if BMS provides it according to the commercial arrangements as mentioned below:

  • A simple discount patient access scheme for nivolumab and a patient access scheme plus commercial access agreement for ipilimumab allow these products to be available to the NHS with a discount