Onco-Summaries: Daily Oncology Updates at a Glance

02/07/2025

Lynozyfic received accelerated approval from the US FDA for R/R Multiple Myeloma (Ref)

• Regeneron Pharmaceuticals announced that the US FDA granted accelerated approval for linvoseltamab-gcpt (Lynozyfic; BCMA x CD3 bispecific antibody) for patients with relapsed or refractory (R/R) multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti‑CD38 monoclonal antibody

• The accelerated approval was granted based on results from the Phase 1/2 LINKER-MM1 trial in which an ORR of 70% and CR of 45% was achieved in heavily pre-treated multiple myeloma patients

• Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial

• To note, the prescribing information for linvoseltamab has a boxed warning for cytokine release syndrome and neurologic toxicity – including immune effector cell-associated neurotoxicity syndrome – in addition to warnings and precautions for infections, neutropenia, hepatotoxicity and embryo-fetal toxicity

Zegfrovy received accelerated approval from the US FDA for NSCLC with EGFR Exon 20 Insertion Mutations (Ref)

• Dizal announced that the US FDA granted accelerated approved for sunvozertinib (ZEGFROVY; EGFR TKI) for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy

  
  

  • The accelerated approval is based on the results from the multinational pivotal Phase 2 WU-KONG1 Part B (WU-KONG1B) trial of sunvozertinib in relapsed or refractory NSCLC with EGFR exon20ins

    
    

  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial

  
  

• Additionally, Dizal has completed enrollment in its multinational Phase 3 pivotal WU-KONG28 trial of sunvozertinib vs platinum-based doublet chemotherapies in treatment naïve NSCLC patients with EGFR exon20ins across 16 countries and regions

The NICE terminated the appraisal of Adagrasib for KRAS mutant NSCLC (Ref)

• The UK's NICE was unable to make a recommendation on BMS' Krazati (adagrasib; small molecule inhibitor of KRAS G12C mutant isoform) for previously treated KRAS G12C mutation-positive advanced NSCLC

• After the first committee meeting, the technology appraisal committee's preferred assumptions included using OS data from the Phase 3 KYRSTAL-12 trial in the economic model

  
  

• However, since this data was immature, BMS will consider restarting this evaluation when the final OS analysis can be included in the economic model