Onco-Summaries: Daily Oncology Updates at a Glance

21/07/2025

Bayer and Orion Corporation’s Nubeqa™ received EU approval for mHSPC (Ref)

• The European Commission granted marketing authorization to Bayer and Orion Corporation’s darolutamide (Nubeqa; oral androgen receptor inhibitor) + androgen deprivation therapy for the treatment of patients with metastatic hormone-sensitive prostate cancer

• The approval was based on results from the pivotal Phase 3 ARANOTE trial in which darolutamide + ADT significantly reduced the risk of radiological progression or death by 46% vs placebo + ADT (HR 0.54; 95% CI 0.41–0.71; P<0.0001) in patients with mHSPC

  
  

• Fred Saad, Professor and Chairman of Surgery and Director of Genitourinary Oncology at the University of Montreal Hospital Center (CHUM), and Principal Investigator of the ARANOTE trial: “Today’s approval of darolutamide plus ADT means that it can now be used with or without chemotherapy, offering physicians greater flexibility to tailor treatment plans to meet the unique needs of their patients and improve clinical outcomes for men with mHSPC. Results from the ARANOTE trial demonstrate that darolutamide plus ADT delays disease progression and extends survival, and just as importantly, due to its high tolerability, enables patients to maintain their daily living with minimal disruption.”

Tagrisso + chemotherapy demonstrated significant OS benefit in EGFR-mutated NSCLC (Ref)

• In the Phase 3 FLAURA2 trial, AstraZeneca’s osimertinib (Tagrisso) + pemetrexed + platinum-based chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the key secondary endpoint of OS vs osimertinib monotherapy as a first-line treatment of locally advanced or metastatic EGFRm NSCLC

  
  

  • Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca: “These exciting overall survival results add to the extensive evidence supporting Tagrisso as the backbone therapy in EGFR-mutated lung cancer, demonstrating that Tagrisso plus chemotherapy can significantly extend survival in the 1st-line advanced setting, in addition to prior trials showing survival benefits as monotherapy in both early stage and advanced disease. With its strong survival benefit and tolerable safety profile, this combination has the potential to help patients live longer while maintaining their quality of life on treatment.”

    
    

  • These data will be presented at a forthcoming medical meeting and shared with global regulatory authorities

Autolus' AUCATZYL CAR-T therapy received EU approval for R/R B-ALL (Ref)

• The European Commission granted marketing authorization for Autolus Therapeutics' obecabtagene autoleucel (AUCATZYL; anti-CD19 CAR-T) for the treatment of adult patients (age 26 and older) with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL)

• The approval follows a positive CHMP opinion, and was based on the results of the Phase 1b/2FELIX trial

• In the pivotal cohort (cohort IIA (n=94)), the CR/CRi for patients who received at least one infusion of obecabtagene autoleucel was 76.6%

  
  

• Median response duration for all infused patients was 21.2 mos, and the median EFS was 11.9 mos

DualityBio's DB-1310 received the Fast Track Designation from the US FDA (Ref)

• The US FDA granted the Fast Track Designation to DualityBio's DB-1310 (HER3-targeting ADC) for the treatment of adult patients with advanced, unresectable or metastatic non-squamous NSCLC with an EGFR exon 19 deletion or L858R mutation with disease progression on or after treatment with a third-generation EGFR TKI and platinum-based chemotherapy.

• In the Phase 1/2a NCT05785741 trial, DB-1310 demonstrated encouraging efficacy and a manageable safety profile in patients with advanced solid tumors who had failed standard therapies

• Dr. Hua Mu, Global Chief Medical Officer, DualityBio: "DB-1310 demonstrated encouraging clinical efficacy and manageable safety in patients with EGFRm nsqNSCLC and multiple solid tumors. It is noteworthy that preclinical investigations of DB-1310 in combination with EGFR TKIs and other anticancer agents have also demonstrated robust synergistic tumor suppression activity. We will spare no effort to accelerate the clinical development of DB-1310 and look forward to its potential, as a next-generation HER3 ADC, to become a novel therapeutic option for a broad population of cancer patients."