Onco-Summaries: Daily Oncology Updates at a Glance

22/12/2025

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• Roche's mosunetuzumab SC received the FDA accelerated approval for follicular lymphoma

  
  

• AstraZeneca and Daiichi Sankyo’s trastuzumab deruxtecan received the FDA breakthrough therapy designation for early breast cancer

• AstraZeneca's ceralasertib + durvalumab failed to meet the OS endpoint in PD(L)-1 failed NSCLC

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Roche's mosunetuzumab SC received the FDA accelerated approval for follicular lymphoma (Ref)

The US FDA granted accelerated approval to Roche's Lunsumio VELO™ (mosunetuzumab; CD20xCD3 BsAb), as a subcutaneous (SC) formulation, 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 study

• Full approval for this regimen may be contingent on verification and confirmation of benefit in a confirmatory trial

• Levi Garraway, CMO and Head of Global Product Development, Roche: “Since follicular lymphoma often requires lifelong management reducing the burden of care for these individuals is of paramount importance. With this FDA approval, treatment can now be administered in just one minute, which significantly reduces the time patients spend in the clinic and helps to align care with their individual needs and preferences.”

AstraZeneca and Daiichi Sankyo’s trastuzumab deruxtecan received the FDA breakthrough therapy designation for early breast cancer (Ref)

The US FDA granted the breakthrough therapy designation to AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan; HER2 ADC) for adult patients with HER2+ve early breast cancer with residual invasive disease in the breast and/or axillary lymph nodes after neoadjuvant treatment and high risk of disease recurrence.

• The BTD is based on results from the Phase 3 DESTINY-Breast05 trial

• Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca: "For patients with residual disease after neoadjuvant treatment, the post-neoadjuvant setting represents a critical opportunity to reduce the risk of recurrence and prevent progression to metastatic disease. This Breakthrough Therapy Designation highlights the impressive clinical benefit of Enhertu over the current standard of care and underscores its potential to become an important treatment option in the post-neoadjuvant setting.”

AstraZeneca's ceralasertib + durvalumab failed to meet the OS endpoint in PD(L)-1 failed NSCLC (Ref)

The Ph3 LATIFY trial of AstraZeneca's ceralasertib (ATR kinase inhibitor) + durvalumab (anti-PD-L1) failed to meet the primary endpoint of OS vs docetaxel in patients with locally advanced or metastatic NSCLC without actionable genomic alterations whose disease progressed on or after prior immunotherapy and platinum-based chemotherapy.

• The combination was generally well tolerated, and no new safety concerns were identified

• Detailed results from the trial remain undisclosed and will be presented at a forthcoming medical meeting

• Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca: “Our goal in the LATIFY trial was to reinvigorate the immune response of patients with lung cancer whose tumours stopped responding to available therapies by combining ATR inhibition with immunotherapy. While we are disappointed by this result, we remain committed to pioneering new medicines to address the urgent need to improve outcomes for patients with lung cancer through our industry-leading portfolio.”