Onco-Summaries: Daily Oncology Updates at a Glance

27/08/2025

BeOne Medicines' perioperative tislelizumab regimen received approval from the EC for resectable NSCLC (Ref)

The EC approved BeOne Medicines' tislelizumab (TEVIMBRA; anti-PD-1) + platinum-containing chemotherapy as neoadjuvant treatment followed by tislelizumab monotherapy as adjuvant treatment for adult patients with resectable NSCLC at high risk of recurrence.

• The approval was based on results from the China-specific Phase 3 RATIONALE-315 trial

  
  

• Per pre-planned final analysis, the regimen elicited a statistically significant and clinically meaningful benefit in OS vs chemotherapy

  
  

• Results will be presented as a LBA (#MA04.08) at WCLC 2025

ExCellThera's Zemcelpro cell therapy received EC authorization for blood cancer patients without access to suitable donor cells (Ref)

The EC granted the conditional marketing authorization to ExCellThera's Zemcelpro (UM171 cell therapy; personalized cryopreserved haematopoietic stem cell transplantation) for the treatment of adults with haematological malignancies requiring an allogeneic haematopoietic stem cell transplantation following myeloablative conditioning for whom no other type of suitable donor cells is available.

• Dr. Fabio Ciceri, Professor of Hematology, Vita-Salute San Raffaele University, Italy: "The curative potential of allogeneic stem cell transplantation is still limited by the access to a suitable donor. The access to stem cell donation according to the stringent disease course is one of the major limiting factors for success. UM171 Cell Therapy offers an option timely available for patients in need."

  
  

• Dr. J. (Jurjen) Versluis, Internist-Hematologist and Principal Investigator, Erasmus MC, The Netherlands: "Each year, thousands of people across Europe are diagnosed with blood cancers that require potentially life-saving allogeneic stem cell transplantation. Yet some are left without access to suitable donor-derived blood stem cells, facing a critical and unmet medical need."

The Phase 3 HERTHENA-Breast04 trial of patritumab deruxtecan in metastatic Breast Cancer has been initiated (Ref) 

The first patient has been dosed in the Phase 3 HERTHENA-Breast04 trial of Daiichi Sankyo and Merck & Co./MSD's patritumab deruxtecan (HER3 ADC) vs investigator’s choice of treatment in patients with unresectable locally advanced or metastatic HR+ve, HER2-ve breast cancer with disease progression following endocrine and CDK4/6 inhibitor therapy in either the adjuvant or first-line metastatic settings.

• Mark Rutstein, Head, Therapeutic Area Oncology Development, Daiichi Sankyo: “Despite significant development in the treatment landscape, HR positive, HER2 negative metastatic breast cancer is a highly complex and challenging disease with an overall poor prognosis. The promising clinical activity observed in our early phase studies including ICARUS-Breast01 suggest that patritumab deruxtecan has the potential to become a meaningful new treatment option for this specific type of breast cancer.”

  
  

• Marjorie Green, Senior Vice President and Head of Oncology, Global Clinical Development, Merck Research Laboratories: “The initiation of HERTHENA-Breast04 demonstrates our ongoing commitment to researching innovative approaches that may help treat some of the most challenging cancers. These patients need new options, and we continue to pursue cutting-edge science to develop therapies that may lead to improved treatment outcomes.”

Lilly's Verzenio + endocrine therapy achieved significant OS benefit in early breast cancer (Ref)

Eli Lilly and Company reported positive topline results from the primary OS analysis of the Phase 3 monarchE trial in which abemaciclib (Verzenio; CDK4/6 inhibitor) + endocrine therapy demonstrated a statistically significant and clinically meaningful improvement in OS vs endocrine therapy alone in patients with HR+, HER2-, node-positive, high-risk early breast cancer.

• 7-year landmark analysis also demonstrated sustained IDFS and DRFS benefit

  
  

• Jacob Van Naarden, Executive Vice President and President, Lilly Oncology: "Preventing disease relapse and helping patients live longer is the ultimate goal and a high bar in the adjuvant setting. Achieving a statistically significant OS benefit with just two years of Verzenio therapy reinforces its differentiated profile in high-risk HR+, HER2- early breast cancer. These data validate Verzenio as the standard-of-care for patients with node-positive, high-risk disease and increase the urgency to ensure all eligible patients are treated."