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KOL Pulse

What's Hot in Hematology/Oncology

Daily DigestWednesday, September 9, 2026

Leading today's oncology KOL conversation on X: FDA Expands Sevabertinib to 1L HER2-Mutant NSCLC. The KOL Pulse Daily Digest: what verified physician voices are discussing on X across the major tumor types, ranked by engagement over the last 48 hours.

Lung Cancer@DoctorDietrichMartin Dietrich, MD, PhD · @DoctorDietrich

“Another win for 1st line Her2mt NSCLC - Sevabertinib ✅ 75% response rate ✅ > 6 months DOR 73% ✅> 12 months DOR 38% AE profile of diarrhea, hepatotoxicity and LV dysfunction. Phase 3 studies will be updated at WCLC in the next week. Best sequence remains unanswered but believe TKIs will remain preferred for most patients in 1st line with responses after ADC appearing significantly impacted, AE profile and PO convenience. A good day for lung cancer.”

View post ↗Read the full SOHO-01 trial profile on KOL Pulse →

FDA Approval FDA grants accelerated approval to sevabertinib (Hyrnuo) for first-line HER2 TKD-mutant non-squamous NSCLC ↗
On September 9, 2026 the FDA expanded sevabertinib's accelerated approval to treatment-naive adults with locally advanced or metastatic non-squamous NSCLC harboring HER2 (ERBB2) TKD activating mutations, by FDA-authorized test.

🫁Lung Cancer
FDA Expands Sevabertinib to 1L HER2-Mutant NSCLC

The FDA granted accelerated approval to sevabertinib (Hyrnuo, Bayer) for first-line treatment of locally advanced or metastatic non-squamous NSCLC with HER2 (ERBB2) TKD activating mutations, based on the SOHO-01 treatment-naive cohort (ORR 75%, with 73% of responders holding response at least six months) — expanding the November 2025 approval in previously treated patients, with confirmatory Phase 3 SOHO-02 ongoing. Global lung KOLs (Dietrich, Horinouchi, Garitaonaindia, Manochakian, OncBrothers) amplified the decision within hours, and the access-equity discussion followed just as fast.

SOHO-01sevabertinibHyrnuoHER2 (ERBB2)SOHO-02
@DoctorDietrich

“Another win for 1st line Her2mt NSCLC - Sevabertinib ✅ 75% response rate ✅ > 6 months DOR 73% ✅> 12 months DOR 38% AE profile of diarrhea, hepatotoxicity and LV dysfunction. Phase 3 studies will be updated at WCLC in the next week. Best sequence remains unanswered but believe TKIs will remain preferred for most patients in 1st line with responses after ADC appearing significantly impacted, AE profile and PO convenience. A good day for lung cancer.”

— @DoctorDietrich · Sevabertinib 1L approval · View post ↗
@HHorinouchi

“🔥 @FDA accelerated approval: sevabertinib (Hyrnuo) for 1L HER2 TKD-mutant non-squamous NSCLC 🆙 @Bayer 🎯SOHO-01 trial 🎯ORR 75% (95%CI 64-85); 73% DOR ≥6 mo; 38% DOR ≥12 mo 🎯Project Orbis review; breakthrough therapy & priority review granted #LCSM @OncoAlert @Larvol @EGFRResisters @Exon20Group”

— @HHorinouchi · Sevabertinib 1L approval · View post ↗
@YGaritaonaindia

“🔥@FDA accelerated approval: sevabertinib in 1L HER2 (ERBB2) TKD-mutant non-squamous #NSCLC ➡️ Expands the Nov 2025 approval in previously treated patients. Confirmatory trial: SOHO-02 vs platinum-pembro.”

— @YGaritaonaindia · Sevabertinib 1L approval · View post ↗
@Latinamd

“Approval is only the first step. Access is the finish line. Excellent @jco piece by @IbiayiMD and an important call to action to ensure post-approval operational readiness after novel drug approvals. We can’t celebrate FDA approval if patients still can’t access the therapy. Sunvozertinib and daraxonrasib are timely examples of the gap between regulatory approval and real-world availability. Speeding to a Stop: Postapproval Barriers to Accessing New Lung Cancer Therapies | Journal of Clinical Oncology https://t.co/tm06wx2HTY #acesstocare”

— @Latinamd · Post-approval access · View post ↗
📌 Amplified by @KolPulseAI
🎗️Breast Cancer

Quiet today — no notable KOL discussion in the last 48 hours.

🔵GI Cancers
GlutaPanc: The Backstory of an Unconventional PDAC Trial

Dr. Jun Gong shared the Nature Cancer research briefing behind the Phase 1 GlutaPanc trial in pancreatic cancer — including the challenge of funding a glutamine-supplementation approach when glutamine deprivation was the field's historical strategy.

GlutaPancPDACglutamine metabolism
@jgong15

“Read the backstory behind the phase I GlutaPanc trial in this @NatureCancer #ResearchBriefing, including challenges in funding this unconventional therapy in #PDAC when glutamine deprivation, not supplementation, was the historical approach https://t.co/iTliZGqV2G @OncoAlert”

— @jgong15 · GlutaPanc Phase 1 (Nature Cancer briefing) · View post ↗
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🔷GU Cancers
Randomized 10-Year Readout Questions Retzius-Sparing RARP

The first randomized long-term readout of Retzius-sparing RARP (post hoc analysis in European Urology Oncology, 120 men, low/intermediate-risk prostate cancer) showed better early continence but worse long-term cancer control — 10-year PFS 50.5% vs 82.0% for the anterior approach — with the caveats of a small trial and surgeon learning curve. Separately in Nature, the Pan Prostate Cancer Group reported that eight integrated mutational footprints explain 85% of primary prostate cancer genomes, with four predicting metastasis independent of standard risk factors.

Retzius-sparing RARPprostate genomicsPan Prostate Cancer GroupCAPRA-SmCRPC
@Adam_Weiner535

“🚨 Retzius-sparing RARP: better early continence, worse long-term cancer control in the first randomized trial 10-yr readout 🚨 @EurUrolOncol, post hoc analysis of an RCT 👥 120 men, NCCN low/intermediate risk PCa, randomized 1:1 RS vs anterior RARP ⏱️ Median f/u 77 mo, 20 progression events (BCR and/or any additional tx) ✅ 5-yr PFS: 80.2% RS vs 91.1% anterior (p=0.01) ✅ 10-yr PFS: 50.5% vs 82.0% ✅ Adjusted for CAPRA-S: HR 2.64 for progression w/ RS (95% CI 1.01 to 6.91) ⚠️ Signal held in negative-margin pts only: 5-yr 81.1% vs 96.1% (p=0.042), so not just a margin story ⚠️ RS arm had more pT3 (45% vs 23%) and numerically more PSMs (25% vs 13%) ⚠️ Small trial, oncology not the original endpoint, only 9 pts at risk at 10 yr, and the 2 surgeons had done just 60 RS cases total. Expert series suggest ~100 to flatten the learning curve 🎯 First randomized long-term evidence that the oncologic equivalence of RS RARP cannot be assumed. 👉Not a final verdict on RS in high-volume hands 🔗 https://t.co/SCHgWNmK7V @AmerUrological @UroOnc @SUO_YUO @PCF_Science @PCFnews @UrologyTimes @urotoday”

— @Adam_Weiner535 · Retzius-sparing RARP 10-yr RCT readout · View post ↗
@Adam_Weiner535

“🚨 8 mutational processes explain 85% of primary #prostatecancer genomes 🚨 @Nature, Pan Prostate Cancer Group: 👥 959 primary tumours w/ WGS, median f/u 7 yrs 📊 SBS + indel + copy number + 6 new complex SV signatures combined into 8 integrated footprints ✅ 4 of them, in 37% of tumours, predicted metastasis independent of age, Gleason, stage, TMB (HRs 4.05 to 7.71) ✅ The same signatures analyzed one at a time predicted nothing, need to know the dominant cluster! ✅ In mCRPC, a replication-stress footprint predicted ARPI over taxane: HR 0.21 for treatment failure ⚠️ Retrospective, ARPI signal rests on 25 pts, WGS of course not routine practice 🎯 Bottom line: we keep asking is it HRD, is it BRCA. Under 3% of primary PCa answer yes. Integrate four kinds of variation instead and you stratify 85% of genomes. 🔗 https://t.co/xn33hwjXR6 @AmerUrological @UroOnc @PCFnews @PCF_Science @SUO_YUO @UroOnc”

— @Adam_Weiner535 · Nature: prostate cancer mutational footprints · View post ↗
🟣Multiple Myeloma & Plasma Cell Disorders
CNS Myeloma: T-Cell Therapies Displacing Intrathecal Treatment

A Mayo Clinic myeloma team analysis in the Blood journals portfolio examined CNS involvement of multiple myeloma, with retrospective results favoring T-cell-based approaches — a shift Dr. Rahul Banerjee summarized as “IT is out and T cells are in,” noting bispecific antibodies are now practical to start.

CNS myelomabispecific antibodiesCAR-T
@RahulBanerjeeMD

“Excellent @BloodPortfolio work by Mayo myeloma team as always. When it comes to CNS involvement of multiple myeloma… IT is out and T cells are in! Obvi some selection bias to any retrospective analysis, but these results speak for themselves. BsAbs easy to start nowadays.”

— @RahulBanerjeeMD · CNS involvement of multiple myeloma · View post ↗
🩸Leukemia & Lymphoma
Myelofibrosis Treatment Algorithm: JAK Inhibitors First

The Oncology Brothers published the myelofibrosis treatment algorithm from their discussion with Dr. Nico Gagelmann — JAK inhibitors regardless of JAK mutation status, sequencing, and supportive care — as the heme community gathered for SOHO 2026 in Houston.

MyelofibrosisJAK inhibitorsSOHO26
@OncBrothers

“This is the algorithm we have used during our discussion with @NicoGagelmann on Myelofibrosis! ✅ JAK Inhibitors (regardless of JAK mutation) ✅ Seqeuncing ✅ Supportive care #OncTwitter #MedTwitter #HemeTwitter @OncUpdates #MPNsm”

— @OncBrothers · Myelofibrosis algorithm (with Dr. Gagelmann) · View post ↗
Compiled and reviewed by the KOL Pulse research team, led by Brian Shields, Founder, KOL Pulse. Quotes are verbatim from physicians' public posts on X and cross-checked by an automated audit. Last updated September 9, 2026.