Onco-Summaries: Daily Oncology Updates at a Glance

24/04/2025

Summary 1 (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

Summary 2 (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

References:

1. https://www.prnewswire.com/news-releases/ivonescimab-in-combination-with-chemotherapy-demonstrates-statistically-significant-and-strongly-positive-results-in-first-line-treatment-of-squamous-non-small-cell-lung-cancer-sq-nsclc-vs-tislelizumab-in-combination-with-chemo-302435143.html

2. https://www.nice.org.uk/guidance/gid-ta10165/documents/674