Your go-to digest for the latest breakthroughs in cancer care.
This week’s digest spans EU approvals in myeloma and lung cancer, precision-driven trials in breast and hematologic oncology, and a biomarker breakthrough in lung adenocarcinoma brain metastasis.
Leading voices. Big insights. Scroll down for Dr. Maria Barbu!
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Sarclisa (Isatuximab) Gains EU Approval in Transplant-Eligible Newly Diagnosed Multiple Myeloma
On July 25, 2025, the European Commission approved Sarclisa combined with VRd (bortezomib, lenalidomide, dexamethasone) as induction therapy for transplant-eligible NDMM. The GMMG-HD7 Phase III trial showed significant MRD negativity and prolonged progression-free survival versus VRd alone.
Clinical insight: This approval broadens Sarclisa’s role to include early disease lines, regardless of transplant eligibility.
(Ref: Sanofi press release citing GMMG-HD7 results and EC approval, July 25, 2025)
CHMP Recommends TEVIMBRA (Tislelizumab) for Resectable NSCLC (RATIONALE-315) Trial
On July 28, 2025, CHMP issued a positive opinion for TEVIMBRA plus platinum-based chemo as neoadjuvant therapy followed by adjuvant monotherapy in high-risk resectable NSCLC. In the Phase III RATIONALE‑315 trial, TEVIMBRA significantly improved MPR (56.2% vs 15.0%), pCR (40.7% vs 5.7%), and event-free survival (HR 0.56; P=0.0003).
Practice relevance: Could establish the first perioperative immunotherapy standard in early-stage NSCLC.
(Ref: BeOne Medicines CHMP recommendation release, July 28, 2025)
TEODOR Trial Launched to Evaluate ct-DNA Guided De-escalation in HR+ Breast Cancer
Natera and ABCSG have initiated the TEODOR Phase II RCT, investigating whether hormone receptor-positive, HER2-negative patients who are ctDNA-negative and endocrine-responsive can safely skip neoadjuvant chemotherapy in favor of endocrine therapy. Primary endpoints are pCR rate and modified PEPI score.
Innovative approach: Personalizes neoadjuvant decision-making via ctDNA and endocrine sensitivity metrics.
(Ref: Natera press release announcing TEODOR trial launch, July 29, 2025)
On July 29, 2025, Lilly announced that pirtobrutinib demonstrated non-inferiority and statistical superiority, in overall response rate versus ibrutinib in treatment-naïve or BTKi-naïve CLL/SLL, in the head-to-head BRUIN CLL‑314 Phase III trial. PFS data is immature but trending favourably.
Clinical takeaway: This is first head-to-head evidence supporting a non-covalent BTK inhibitor in frontline CLL/SLL.
(Ref: Lilly press release with BRUIN trial topline results, July 29, 2025)
Neuronatin (NNAT) Overexpression Predicts Brain Metastatis and Poor Survival in Lung Adenocarcinoma
A retrospective study of 200 lung adenocarcinoma patients (33 with brain metastasis) showed that nuclear NNAT immunopositivity corresponded with significantly shorter overall survival (7.6 vs 24.4 months) and independently predicted brain metastasis risk. NNAT-IRS positivity was similarly linked to diminished outcomes.
Translational insight: NNAT may serve as a valuable early prognostic biomarker to stratify high-risk patients for brain-directed surveillance and intervention.
(Ref: Basaran Goksen et al. Scientific Reports 2025;15:27653)
This week’s Oncology Spotlight: Dr. Maria Barbu on Cancer Care in Romania!
In this week’s special segment from IUCS 2024, we speak with Dr. Maria Barbu, a medical oncologist from Bucharest, Romania. CLICK HERE TO WATCH!
Dr. Barbu shares her perspective on the evolving oncology landscape in Eastern Europe, particularly in the treatment of prostate cancer.Explore more stories & insights on ONCOassist. Your clinical edge, just a tap away.Â
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