Oncology Updates - Key Oncology News
September 3rd Week, 2026
Regulatory Events
🎯 AstraZeneca’s sBLA for perioperative durvalumab (Imfinzi; anti-PD-L1) + Astellas Pharma and Pfizer’s neoadjuvant enfortumab vedotin (Padcev; Nectin-4 ADC) was accepted and granted Priority Review by the US FDA for the Tx of MIBC patients who are ineligible/have declined cisplatin-based chemotherapy (Ref1)
❓ What are the current efficacy benchmarks for perioperative MIBC?
🎯 The US FDA approved Merck&Co/MSD's belzutifan (Welireg; HIF-2alpha inhibitor) + Eisai US & Merck&Co./MSD's lenvatinib (Lenvima; multi-kinase inhibitor) in post-IO advanced ccRCC, based on PFS superiority over cabozantinib (multi-TKI), despite no statistically significant OS benefit (Ref2)
❓ What is the current SOC for ccRCC?
🎯 The US FDA approved Elevar Therapeutics’ lirafugratinib (Lyrfigtu; FGFR2 inhibitor) for the Tx of adults with cholangiocarcinoma (CCA) and FGFR2 fusion or other rearrangement (Ref3)
❓ How is Lyrfigtu positioned in the CCA landscape?
🎯 The US FDA requested additional OS evidence for Compass Therapeutics Inc.’ tovecimig (DLL4 x VEGF-A BsAb) in biliary tract cancer (BTC), prior to submitting a BLA, despite positive ORR and PFS results reported in the Ph2/3 COMPANION-002 study (Ref4)
❓ Who are the key competitors to tovecimig in the BTC landscape?
⭐ The US FDA granted Fast Track designation for osteosarcoma and an Orphan Drug designation for soft tissue sarcoma (STS) to SOTIO Biotech’s SOT106 (LRRC15 ADC) (Ref5)
❓ Which are the key assets in the STS developmental landscape?
Clinical Updates
🔬 In the Ph3 EXCALIBER-RRMM trial, Bristol Myers Squibb’s iberdomide (Zenbexus; CELMoD agent) + J&J’s daratumumab (Darzalex; anti-CD38) + dexamethasone (glucocorticoid) therapy significantly improved response depth and MRD-negative CR versus daratumumab + dexamethasone + bortezomib (proteasome inhibitor) in r/r MM patients. (Ref6)
❓ How is BMS’ regimen positioned in the RRMM market landscape?
🔬 Johnson & Johnson Innovative Medicine reported new MCM-based analyses from the Ph3 MajesTEC-3 study showing sustained DCR and survival with teclistamab-cqyv (Tecvayli; BCMA x CD3 bispecific TCE) + daratumumab and hyaluronidase-fihj (Darzalex Faspro) in 2-4L r/r MM (Ref7)
❓ What are the current clinical benchmarks for ≥2L MM?
Setbacks
🛑 Merck&Co/MSD and Daiichi Sankyo withdrew their US BLA seeking accelerated approval of ifinatamab deruxtecan (I-DXd; B7-H3 ADC) for Tx of adults with ≥2L ES-SCLC, due to insufficient data from the Ph2 IDeate-Lung01 trial to support the application. (Ref8)
❓ How does the withdrawal alter I-DXd's position in the ES-SCLC developmental landscape?
👉 To know answers to these questions and for additional insights, write to us at support@oncofocus.com.
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