Onco-Summaries: Daily Oncology Updates at a Glance

19/11/2025

Roche's Lunsumio SC received conditional approval in EU for R/R FL (Ref)

The European Commission granted conditional marketing authorisation to Roche's mosunetuzumab (Lunsumio; CD20 x CD3 bispecific antibody) subcutaneous (SC) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. 

• The approval is based on results from the Phase I/II GO29781 trial in which Lunsumio SC had pharmacokinetic non-inferiority compared with intravenous administration, with no unexpected safety signals

• Lunsumio SC is a fixed-duration treatment that can be initiated in the outpatient setting and has the potential to substantially reduce treatment administration time with an approximately one-minute injection, compared with a 2-4 hour IV infusion

Merck & Co./MSD's KEYTRUDA SC received approval in EU for all previously approved KEYTRUDA indications (Ref)

The European Commission granted approval to Merck & Co./MSD's subcutaneous formulation of pembrolizumab (KEYTRUDA SC™, anti-PD-1) for use across all 33 KEYTRUDA indications for adult patients in Europe. 

• KEYTRUDA SC is a co-formulation of pembrolizumab and berahyaluronidase alfa, which is a variant of human hyaluronidase developed and manufactured by Alteogen Inc

  
  

• The approval of KEYTRUDA SC is based on results from the pivotal Ph3 3475A-D77 trial, which compared KEYTRUDA SC and KEYTRUDA, both administered every six weeks, each in combination with chemotherapy, in patients with treatment naïve metastatic NSCLC

Regeneron Pharmaceuticals' adjuvant Libtayo received approval in EU for high-risk CSCC (Ref)

The European Commission granted approval to Regeneron Pharmaceuticals' cemiplimab (Libtayo; PD-1 inhibitor) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation.

• The approval is based on results from the Phase 3 C-POST trial, which evaluated adjuvant Libtayo versus placebo in patients with CSCC at high risk of recurrence following surgery and radiation

• Libtayo demonstrated a 68% reduction in the risk of disease recurrence or death compared to placebo (HR 0.32; p<0.0001)

Amgen's Imdelltra received the FDA full approval for ES-SCLC (Ref)

The US FDA granted full approval to Amgen's tarlatamab (IMDELLTRA®; DLL3–targeting Bispecific T-cell Engager) for the treatment of adult patients with extensive stage SCLC with disease progression on or after platinum-based chemotherapy.

• The decision to convert the prior accelerated approval to a full approval is based on data from the global Phase 3 DeLLphi-304 trial

• Additionally, the NCCN Guidelines were updated to include tarlatamab as the only Category 1 preferred treatment option for adult patients with ES-SCLC with disease progression on or after platinum-based chemotherapy

Bayer's Hyrnuo received the FDA accelerated approval of HER2 mutant, non-sq NSCLC (Ref)

The US FDA granted accelerated approval to Bayer's sevabertinib (Hyrnuo, kinase inhibitor) for adults with locally advanced or metastatic, non-squamous NSCLC whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.

• The approval is based on the Ph1/2 SOHO-01 (NCT05099172), an open-label, single-arm, multicenter, multi-cohort clinical trial

• The FDA also approved the Oncomine Dx Target Test (Life Technologies Corporation) as a companion diagnostic device to aid in detecting HER2 (ERBB2) TKD activating mutations in patients with non-squamous NSCLC who may be eligible for treatment with sevabertinib