Oncology Updates - Key Oncology News

April 4th Week, 2025

Regulatory & Market News

🎯 Akeso Biopharma’s penpulimab-kcqx (anti-PD-1) + chemo received the US FDA approval for the Tx of previously untreated recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (nkNPC).

👉 The FDA also approved single agent penpulimab-kcqx for the Tx of nkNPC patients who have progressed following platinum chemo and at least one other prior line of therapy. (Ref 1)

❓ How does this approval affect the current Tx landscape of NPC?

🎯 Bristol Myers Squibb’s nivolumab (Opdivo; anti-PD-1) + BMS’ ipilimumab (Yervoy; anti-CTLA-4) received the NICE recommendation for reimbursement for the Tx of patients with previously untreated MSI-H/dMMR metastatic/unresectable Colorectal Cancer (CRC) (Ref 2)

❓ How would this impact other companies looking to enter CRC space?

🎯 Daiichi Sankyo filed a supplemental NDA to Japan’s MHLW for extension of trastuzumab deruxtecan’s (Enhertu; HER2 ADC) indication to include solid tumors that are HER2 overexpressed (IHC 3+) or amplified (ERBB2) and are refractory or intolerant to standard treatments. (Ref 3)

❓ Are there any tumor-agnostic treatments approved in Japan currently?

Clinical Updates

🔬 Per interim analysis of the Ph3 DESTINY-Breast09 trial, AstraZeneca and Daiichi Sankyo’s trastuzumab deruxtecan (Enhertu; HER2 ADC) + Roche’s pertuzumab (Perjeta; anti-HER2/neu) demonstrated statistically significant and clinically meaningful improvement in PFS vs THP (taxane, trastuzumab and pertuzumab) in patients with previously untreated HER2+ Breast Cancer. (Ref 4)

❓What is the current benchmark for PFS in HER2+ Breast Cancer?

🔬 In a China-specific Ph3 AK112-306/HARMONi-6 trial, Akeso BioPharma and Summit Therapeutics, Inc.'s ivonescimab (PD-1 x VEGF BsAb) + chemo met primary endpoint of PFS vs BeiGene's tislelizumab (anti-PD-1) + chemo as a first-line Tx in advanced squamous NSCLC. (Ref 5)

❓ When are the results of the first global Phase 3 trial of ivonescimab in NSCLC expected to be available?

🔬 In a Ph3 ASCENT-04/KEYNOTE-D19 trial, Gilead Sciences 's sacituzumab govitecan-hziy (Trodelvy; TRP2 ADC) + Merck&Co/MSD's pembrolizumab (Keytruda; anti-PD-1) demonstrated statistically significant and clinically meaningful improvement in PFS vs pembrolizumab + chemo in patients with previously untreated, locally advanced or metastatic, PD-L1+ (CPS ≥ 10) TNBC.

👉 Additionally, an early trend in improvement for OS (key secondary endpoint) was observed in sacituzumab Tx arm (Ref 6)

❓ Can the sacituzumab + pembro regimen become a new standard of care?

🌐 References:

1) https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-penpulimab-kcqx-non-keratinizing-nasopharyngeal-carcinoma

2) https://www.thepharmaletter.com/nice-recommends-nhs-use-of-opdivo-and-yervoy-combo-for-mcrc

3) https://www.daiichisankyo.com/files/news/pressrelease/pdf/202504/20250424_E.pdf

4) https://www.astrazeneca.com/media-centre/press-releases/2025/enhertu-combination-improved-pfs-in-1l-her-positive-mbc.html

6) https://www.akesobio.com/en/media/akeso-news/250423/

7) https://www.gilead.com/news/news-details/2025/trodelvy-plus-keytruda-demonstrates-a-statistically-significant-and-clinically-meaningful-improvement-in-progression-free-survival-in-patients-with-previously-untreated-pd-l1-metastatic-trip