Oncology Updates - Key Oncology News

March 4th Week, 2025

Regulatory Events

🎯 CStone Pharmaceuticals submitted a Type II variation application to the EMA for sugemalimab (Cejelmy; anti-PD-L1) to treat stage III NSCLC patients who have not progressed following concurrent or sequential platinum-based CRT. (Ref 1) 

❓ How do sugemalimab’s outcomes compare with those of previously approved AstraZeneca’s durvalumab?

Special Designations 

⭐ Shandong Boan Biotechnology's BA1302 (a first-in-class CD228-directed ADC) has been granted ODD by the US FDA for Tx of sqNSCLC and pancreatic cancer. (Ref 2) 

❓ How many ADCs are under development for NSCLC and pancreatic cancer?

Clinical Events

🔬 Johnson & Johnson’s Ph3 MARIPOSA of amivantamab (Rybrevant; EGFR/MET BsAb ) + Johnson & Johnson & Yuhan's lazertinib (Lazcluze; EGFR TKi) demonstrated statistically significant and clinically meaningful OS improvement vs AstraZeneca’s osimertinib (Tagrisso; EGFR TKi) in 1L NSCLC with EGFR ex19del or L858R mutations. (Ref 3) 

❓ Are there any regimens in pipeline with potential to challenge the MARIPOSA regimen?

🔬 Merck&Co./MSD’s Ph3 3475A-D77 trial demonstrated noninferior PK for SC pembrolizumab (anti-PD-1) + ALTEOGEN Inc.’s berahyaluronidase alfa + chemo vs IV pembrolizumab + chemo. (Ref 4)

❓ What impact will SC pembrolizumab have on the market share of SC nivolumab and SC atezolizumab? 

Deals & Collaborations

🤝 Relmada Therapeutics, Inc signed a licensing agreement with Trigone Pharma for NDV-01 (novel sustained-release intravesical formulation of gemcitabine and docetaxel) (Ref 5)

❓ How does the safety profile of NDV-01 compare with other chemo regimens?

🤝 Bayer AG obtains exclusive worldwide development and commercialization license for Suzhou Puhe BioPharma’s PH020/BAY3713372 (PRMT5 inhibitor) (Ref 6) 

❓ Which other companies have assets targeting PRMT5? 

Setbacks

🛑 In the Ph2 BO44178 trial, Roche’s tobemstomig  (PD-1 x LAG-3 BsAb) + chemo failed to show clinical benefit vs pembrolizumab + chemo in 1L NSCLC patients. (Ref 7)

❓ Is tobemstomig being studied in other cancer types? 

To know answers to these questions and for additional insights, write to us at support@oncofocus.com.

🌐 References:

1) https://www.cstonepharma.com/en/html/news/3787.html

2) https://www.boan-bio.com/en/info.php?id=352

3) https://www.jnj.com/media-center/press-releases/rybrevant-amivantamab-vmjw-plus-lazcluze-lazertinib-outperforms-osimertinib-with-a-significant-and-unprecedented-overall-survival-benefit-in-patients-with-egfr-mutated-non-small-cell-lung-cancer

4) https://www.merck.com/news/mercks-investigational-subcutaneous-pembrolizumab-with-berahyaluronidase-alfa-demonstrates-noninferior-pharmacokinetics-compared-to-intravenous-iv-keytruda-pembrolizumab-in-pivotal/

5) https://www.relmada.com/for-investors/news/detail/309/relmada-therapeutics-licenses-phase-2-bladder-cancer

6) https://www.bayer.com/media/en-us/bayer-and-puhe-biopharma-enter-into-global-license-agreement-for-clinical-phase-i-prmt5-inhibitor/

7) https://medically.roche.com/global/en/oncology/elcc-2025/medical-material/ELCC-2025-presentation-nadal-a-phase-II-trial-of-tobemstomig-tobe-platinum-based-chemotherapy-pdf.html