Onco-Summaries: Daily Oncology Updates at a Glance

07/04/2026

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• Corbus Gains FDA Alignment on CRB‑701 Registrational Trials in HNSCC and Cervical Cancer

• Nuvalent Submits NDA for Neladalkib in ALK+ NSCLC

• NextCure Receives Fast Track Designation for SIM0505 (CDH6 ADC) in Ovarian Cancer

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Corbus Gains FDA Alignment on CRB‑701 Registrational Trials in HNSCC and Cervical Cancer (Ref)

Corbus reached broad agreement with the FDA on the registration path for CRB-701, a next-generation Nectin-4 targeting antibody-drug conjugate (ADC), in second-line head and neck squamous cell carcinoma (HNSCC) and cervical cancer.

Study Designs:

• HNSCC: Randomized controlled trial of CRB-701 vs physician’s choice chemotherapy

  
  

  • Accelerated approval: based on objective response rate (ORR)

  
  

  • Full approval: based on overall survival (OS)

• Cervical cancer: Randomized controlled trial of CRB-701 vs physician’s choice chemotherapy or Tivdak

  
  

  • Accelerated approval: ORR

  
  

  • Full approval: OS

• Upcoming Data: Updated monotherapy results from Phase 1/2 trials will be presented at ASCO 2026 (May 29–June 2, Chicago), including durability of response and subgroup analyses. Combination data with Keytruda® in first-line HNSCC expected in Q4 2026

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Nuvalent Submits NDA for Neladalkib in ALK+ NSCLC (Ref)

• Nuvalent has submitted a New Drug Application (NDA) to the FDA for neladalkib, an investigational ALK-selective inhibitor, for TKI pre-treated advanced ALK-positive NSCLC

  
  

  • The application is supported by data from the global Phase 1/2 ALKOVE-1 trial in which neladalkib demonstrated encouraging overall activity, including intracranial responses, the ability to address key drivers of disease progression, and a generally well-tolerated safety profile consistent with its ALK-selective, TRK-sparing design

• Designations: Neladalkib has received:

  
  

  • Breakthrough Therapy Designation (for patients previously treated with ≥2 ALK TKIs)

    
    

  • Orphan Drug Designation (for ALK-positive NSCLC)

    
    

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NextCure Receives Fast Track Designation for SIM0505 (CDH6 ADC) in Ovarian Cancer (Ref)

• NextCure’s investigational therapy SIM0505 (CDH6 ADC) has received Fast Track designation for treating platinum-resistant ovarian cancer (PROC)

• Upcoming Data: Phase 1 data will be presented at ASCO 2026 and Dose optimization in ovarian cancer patients is expected to begin in Q2 2026

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