What's Hot in Hematology/Oncology

“HUGE NEWS! Sunvozertinib is FINALLY available to patients in the US! A much-needed oral option for our patients. ORR: 46% Median DOR: 11.1 months Key AEs: Diarrhea (73%), rash (60%), stomatitis (40%).”

“Sunvozertinib finally now available in the US - over one year since its FDA approval on July 2, 2025 for EGFR exon 20 insertion positive NSCLC after prior chemotherapy. Approval based on WU-KONG1B with RR 46%, mDOR 11.1 months.”

“🔥DeLLphi-304: Tarlatamab in Previously Treated SCLC: Extended Follow-Up of Overall Survival From the Phase 3 Trial 🎙️ @charlesrudin 🔢3808O 🎯Durable OS Benefit at 23-Mo Median Follow-Up 🎯mOS 13.6 vs 8.4mo (HR 0.62); 18-Mo OS 42% vs 24% 🎯Grade≥3 TRAEs 28% vs 63%”

“At #ESMO26, extended follow-up from phase III DeLLphi-304 strengthens the case for tarlatamab after first-line platinum-based chemotherapy. 🫁 n=509 | median follow-up 23 months ➡️ Median OS: 13.6 vs 8.4 months HR 0.62 (0.51–0.76) ➡️ 18-month OS: 42% vs 24% ➡️ In patients with baseline brain metastases: OS HR 0.52 (0.38–0.70) And importantly: ⚠️ Grade ≥3 TRAEs: 28% vs 63% with chemotherapy 🎯 Why this matters: in a disease where durable second-line benefit has historically been difficult to achieve, tarlatamab is delivering both meaningful survival improvement and a more favorable high-grade toxicity profile. For me, the brain-metastases subgroup is especially compelling and deserves close attention as we refine where DLL3-targeted therapy fits in the treatment pathway.”

“🔥 Exciting update on our encorafenib + binimetinib efficacy data from the @IFCTlung ONCOBRAF Phase II trial in 1L & 2L BRAF V600E-mut NSCLC! Now a new therapeutic standard in many countries for our BRAF pts (vs. dabrafenib + trametinib). A must-see poster at #ESMO26”

“NATALEE at 6 years: Ribociclib + NSAI vs NSAI alone in HR+/HER2− early breast cancer: • 6-year OS: 91.86% vs 89.73% • OS HR 0.809 (95% CI 0.661–0.989); nominal 1-sided P=0.019 • Absolute OS benefit: 2.1% • 6-year iDFS: 83.23% vs 77.92% • iDFS HR 0.741 (95% CI 0.646–0.849) • Absolute iDFS benefit: 5.3% Is OS significant? Looking forward to full data .”

“NATALEE OS: no formal significance; the analysis is descriptive (nominal P, no alpha). monarchE, by contrast, had a prespecified alpha-controlled OS analysis and met it. NATALEE: HR ~0.80 stable, Δ2.1%, BCSS supportive. Clinically meaningful, not confirmatory.”

“Not ready to call NATALEE an OS win. The p=.019 is one sided and nominal, on the 5th look at survival. More than twice as many control pts dropped out right after randomization, and post-relapse CDK4/6i use in the control arm hasn't been reported .”

“#ESMO26 | TALENT Neoadjuvant T-DXd showed very low pCR rates in HR+/HER2-low early breast cancer: - T-DXd: 7% - T-DXd + anastrozole: 3% - T-DXd → chemotherapy: 9% We should remember that pCR is a limited surrogate endpoint in HR+ disease. However, these results do not support T-DXd as an alternative to standard neoadjuvant chemotherapy. Moreover, given the heterogeneity of HER2-low disease, I find it unsurprising that the success of T-DXd in the metastatic setting does not translate into similar outcomes in early-stage disease, despite the lower tumor burden.”

“🚨 PANKU-Breast01 | ESMO 2026 | LBA50 TWO TARGETS. DOUBLE THE PFS. BUT WHAT ABOUT SURVIVAL? Phase III trial of izalontamab brengitecan (iza-bren), a bispecific EGFR/HER3 ADC, in previously treated HR+/HER2− advanced breast cancer. 🔹 N = 383 | Iza-bren vs physician's choice chemotherapy 🔹 Median PFS: 8.18 vs 4.01 months 🔹 HR 0.41 — 59% lower hazard of progression or death 🔹 ORR: 40.5% vs 20.2% 🔹 ILD: 1.1%, all grade 1–2 ⚠️ OS immature. Optimal ADC sequencing remains unresolved. TAKE-HOME Dual EGFR/HER3 targeting nearly doubles median PFS, but an overall survival advantage remains unproven.”

“@pfizer has withdrawn its #EMA application for #palbociclib in HR+/HER2+ advanced breast cancer following the #PATINA trial results. PATINA showed a significant investigator-assessed PFS benefit, but EMA raised concerns because blinded independent central review did not clearly confirm the magnitude of benefit in this open-label study.”

“🚨 PATINA: The EMA questions a 15-month PFS gain (HR 0.75). I highly recommend 📖https://t.co/pIPlN34KPj by @Timothee_MD: An open-label trial, investigator-assessed PFS, and estimated early censoring of 12.1% in controls vs 5.3% with palbociclib. Robust benefit or potential assessment bias?”

“Frankly, Pfizer’s withdrawal of its application following the EMA’s concerns about efficacy and potential bias is surprising, given that the FDA approved the indication based on PATINA data. Same trial, two different regulatory approaches… Open-label trials, investigator assessment, censored data… Yet I recall that the HR did not change much with independent review either.”

“EMA has raised concerned over Patina trial results . Company has withdrawn the application at EMA for said indication .EMA feels results may have been biased ??”

“🚨 ESMO 2026 | RASolute 302 (LBA82) Phase III: Daraxonrasib (RAS-ON inhibitor) vs chemotherapy in previously treated mPDAC (N=500). 🔹 Median OS: 13.2 vs 6.7 months (HR 0.40) 🔹 Median PFS: 7.2 vs 3.6 months (HR 0.49) OS benefit by RAS mutation: • G12D: HR 0.49 • G12V: HR 0.32 • G12R: HR 0.61 • Q61: HR 0.37 • No RAS mutation identified: HR 0.43 A remarkable 60% reduction in the hazard of death overall, with consistent directional benefit across RAS subgroups.”

“🚨 SANO | ESMO 2026 | LBA78 SAVE THE OESOPHAGUS. BUT AT WHAT COST? Can we safely avoid oesophagectomy after complete clinical response to neoadjuvant chemoradiotherapy? 🔹 SANO 5-year results (N=309) Active surveillance vs surgery: • 5-year OS: 50% vs 54% (HR 1.17) • DFS: HR 1.39 • Distant metastases: 46% vs 29% (P < 0.01) • 43% avoided an oesophagectomy classified as non-beneficial. ⚠️ The paradox: No statistically significant OS difference, yet 17 percentage points MORE distant metastases with surveillance. TAKE-HOME Organ preservation is feasible in selected patients, but long-term oncological equivalence remains uncertain. Careful selection, intensive surveillance and access to salvage surgery are essential. Are we preserving the oesophagus at the cost of distant disease control?”

“🚨 ESMO 2026 | G-HOPE-001 (LBA77) Impressive phase III results for arcotatug tavat ecan (IBI343), a CLDN18.2-targeted ADC, in heavily pretreated advanced gastric/GEJ cancer. IBI343 vs physician's choice chemotherapy (N=408) 🔹 mPFS: 5.5 vs 2.9 months (HR 0.47; p<0.0001) 🔹 mOS: 9.9 vs 7.4 months (HR 0.63; immature) 🔹 ORR: 23.6% vs 5.3% 🔹 Grade ≥3 AEs: 45.8% vs 57.9% 🔹 ILD: 0%”

“🚀Upper GI oral abstracts #ESMO26 Day 1 summary results 1) Arcotatug tavatecan improved PFS in CLDN18.2+ G/GEJA in the 3L+ setting 2) SANO trial, OS at 5 years similar between active surveillance and surgery in patients with oesophageal cancer and a complete clinical response after nCR, despite more distant metastasis 3) Adding pembrolizumab to dCRT did not improve EFS in untreated unresectable esophageal or GEJ cancer with PD-L1 CPS ≥10 4) Daraxonrasib demonstrated consistent OS benefit in different RAS mutatin subgroups in RASolute-302 5) mKRAS-specific lymph node targeted amphiphile immunotherapy in PDAC did not met primary DFS endpoint. 6) Zani + CT +/- tisle keep OS benefit in at IA2 of HERIZON-GEA-01 7) Anbenitamab plus ChT improved OS in patients with HER2-positive GC/GEJC adenoca after previous trastuzumab 8) TQB2102 (HER2 bispecific antibody-drug conjugate) plus bemotrizumab and capecitabine demonstrates promising antitumor activity in 1L of advanced GC/GEJC 9) Dostarlimab in Pts with localized dMMR/MSI-H GEA led to a 62.5% 1y-cCR at the first interim analysis, enabling organ preservation. 10) FOLFIRI and Ram vs paclitaxel in taxan-pretreated GEA imporved PFS but no OS 11) Stage II–IIIB gastric cancer after D2 resection, four months of adjuvant XELOX was noninferior to six months for 3-year DFS 12) Adding durvalumab to dCRT in locally advanced esophagus carcinoma did not improve PFS 13) Adding SBRT to MFOLFIRINOX in high risk, borderline resectable or locally advanced pancreatic cancer mproved LRR and PFS 14) FGFR2b expressing GC/GEJ with co-existing FGFR2 amp may define a biologically distinct subset with potential sensitivity to bemarituzumab”

“Perioperative EVP for MIBC approved in Europe by the EMA irrespective of platinum eligibility. This is based on B15/KN905 with ⬆️ ⬆️ pCR, EFS & OS vs previous standard of care. More patients will get systemic therapy (cisplatin obstacles won’t exist) and these patients will have better outcomes. Will VOLGA tell us more about the optimal number of cycles #ESMO26 ? Which patients don’t need surgery (EV209, EV309, TROFUSE55). Will ctDNA help us?”

“The European Commission approves perioperative enfortumab vedotin + pembrolizumab for resectable MIBC, regardless of cisplatin eligibility! A major milestone for our patients. Now looking forward to VOLGA at the Presidential Symposium on Saturday! @tompowles1 With only 3 neoadjuvant EV cycles and no adjuvant EV, VOLGA could provide important insights into a key question: How much EV do we really need? Does adjuvant EV add meaningful efficacy—or mainly cumulative toxicity? Cross-trial comparisons cannot answer this definitively. Biomarker-guided de-escalation trials are urgently needed! 🔬”

“At #ESMO26, the final prespecified analysis of KEYNOTE-564 confirms that adjuvant pembrolizumab delivers a durable benefit after nephrectomy in high-risk clear-cell #RCC. 📊 n=994 | median follow-up 85.9 months ➡️ DFS: HR 0.68 7-year DFS: 57.2% vs 44.6% ➡️ OS: HR 0.70 7-year OS: 82.3% vs 76.6% ✅ No new serious treatment-related safety signals 🎯 Why this matters: this is no longer just an early DFS story. With mature follow-up, the survival benefit remains clinically meaningful and reinforces pembrolizumab as a true adjuvant standard in ccRCC at increased risk of recurrence. For me, the next question is not whether adjuvant pembrolizumab works — it is how to refine selection further so we identify who needs treatment most, and who may safely avoid it.”

“It has been nearly 5 months since the FDA approved durvalumab + BCG for “BCG-naïve” high-risk #NMIBC based on the POTOMAC trial. There has been considerable discussion about the discordant results of the recent phase III trials evaluating BCG + immune checkpoint blockade. But I think we're overlooking a potentially important difference between these trials, one that could have major implications for how we interpret the results and counsel our patients. POTOMAC and CREST were positive trials, but unlike the negative ALBAN trial, both permitted enrollment of patients previously treated with BCG. To my knowledge, neither has reported how many patients had prior BCG exposure or whether the benefit of adding checkpoint blockade differs between previously treated and truly BCG-naïve patients. Given the additional toxicity, treatment burden, and cost of systemic checkpoint blockade, how can we adequately counsel patients receiving BCG for the first time without knowing the magnitude of benefit specifically in patients like them? I think we need to see these subgroup data from @AstraZeneca and @pfizer .”

“In 2006 we reported 44 patients with non-muscle-invasive micropapillary bladder cancer treated at MD Anderson. 27 got BCG. At a median 30 months, only 5 of them were disease-free with their bladder in place. Twenty years on, we went back to the literature to ask whether that picture still holds. New meta-analysis in @EurUrolOncol”

“I am proud to announce the launch of the US Myeloma Network (USMN) by the International Myeloma Foundation. @IMFmyeloma The USMN will conduct clinical trials including phase III randomized controlled trials. @JNJInnovMed is our first industry partner. @SarahCannonDocs will be our CRO.”

“GPRC5D vs BCMA bispecifics, 27 studies, 4,045 pts. ORR 70% vs 61%, but that's cross-study pooling. I wouldn't rank on it. The toxicity split is the real takeaway: BCMA - grade 3-4 infections 26% GPRC5D - taste changes 70%, nails 42%, almost never grade 3-4 Diffrent target, different supportive care plan.”

“Can MRD define CURE? Who can safely STOP maintenance? The proposed IMS/IMWG definition requires ≥5 years OFF therapy, sustained CR, MRD negativity (10⁻⁶), and negative imaging. Stop maintenance at year 2? Cure designation no earlier than year 7. Stop at year 5? Year 10! But who can safely stop, and when? SWOG S1803 (DRAMMATIC), led by Amrita Krishnan, asks exactly that question: STOP vs CONTINUE maintenance in MRD-negative patients. Excellent trial design! But the key endpoint is OS. My concern? By the time OS matures, many of us may have retired! 😂 More importantly, bispecifics and CAR-T may become earlier standards of care, with trispecific antibodies emerging as salvage therapy. Will the results still change practice? My take: For selected standard-risk patients with sustained deep MRD negativity, I would discuss stopping maintenance. Not for high-risk disease or a single MRD-negative snapshot. What I really want to know is whether stopping compromises survival, and how much treatment-free, high-quality life patients gain.”

“Legend Biotech has received FDA IND clearance for LB2501, an investigational in vivo CAR-T therapy designed to generate CD19/CD20 dual-targeting CAR-T cells directly inside the patient after a single infusion. Unlike conventional autologous CAR-T, LB2501 is designed to be off-the-shelf, potentially eliminating several steps of individualized cell collection and manufacturing. Notably, the planned U.S. Phase 1/2 study will evaluate the therapy without lymphodepleting chemotherapy. LB2501 uses Legend’s TaVec™ platform, an engineered, replication-incompetent lentiviral vector designed to selectively transduce T cells in vivo. The resulting CAR-T cells target both CD19 and CD20—a strategy intended to reduce the risk of antigen escape in B-cell malignancies. If successful, this could address some of the biggest barriers to conventional CAR-T: manufacturing time, complexity, scalability, and access. But the critical questions now move from engineering to the clinic: Can we reliably generate enough functional CAR-T cells in vivo? Will the cells expand and persist appropriately? What will the safety profile look like without traditional lymphodepletion? And can dual targeting translate into deeper and more durable responses? LB2501 is now moving toward U.S. clinical evaluation, adding another important step in the rapidly developing field of in vivo cell engineering. The next generation of CAR-T may not be manufactured for the patient—it may be manufactured inside the patient.”

“New EHA #FollicularLymphoma guidelines: From 1st relapse, R2 ± tafa or epcor goes ahead of immunochemo. After 2nd relapse: single-agent bispecific, CAR T or zanu-O. Chemo at relapse = exception, not default. About time.”