Harold J. Burstein, MD, PhD, FASCO · @DrHBurstein“The issues here are more market than medical. To date, the test does not work to facilitate early detection of cancer. The study did not meet its primary endpoint. The biggest signal was in colorectal cancer but the UK (where study was done) does not have widespread screening colonoscopy, as does US, so meaning unclear for American health. See @ASCO data slides for Galleri study: https://t.co/XExvteheyO See Lancet editorial: https://t.co/rWhazkGAZP”
View post ↗KOLs weigh the Galleri evidence ahead of the FDA panel — read the KOL Pulse breakdown →Update, evening of Sept 23: the FDA's Molecular and Clinical Genetics Panel voted on GRAIL's Galleri PMA — safety 10–0–0, effectiveness 6–4, and benefits-outweigh-risks 7–2–1, a non-binding endorsement STAT's Matthew Herper called “fairly tepid.” The panel also leaned toward dropping “early” from the proposed indication, calling it simply a “multi-cancer detection” test. The FDA has not approved Galleri; a decision on the PMA is still pending.
Full vote breakdown, verbatim KOL reaction & sources on the NHS-Galleri trial profile →
“New FDA approval for bile duct cancer (cholangiocarcinoma).✅ Lirafugratinib is now approved for previously treated advanced disease with an FGFR2 gene fusion or rearrangement. In the REFOCUS trial…”
— @ilyassahinMD · View post ↗
“Daraxonrasib has been added to NCCN guidelines for KRASmt non-small cell lung cancer. Dose at 200 mg instead of 300. Great speed, many patients that will benefit from this swift inclusion. @RevMedicines”
— Martin Dietrich, MD, PhD · @DoctorDietrich · View post ↗The ESMO 2026 late-breaking abstract titles are out, and thoracic oncologists went straight to the Presidential lineup: three phase 3 lung readouts — DeLLphi-305 (tarlatamab plus durvalumab as first-line maintenance in extensive-stage SCLC), KRASCENDO-1 (divarasib head-to-head against sotorasib or adagrasib in previously treated KRAS G12C NSCLC), and SAFFRON (savolitinib plus osimertinib in MET-driven EGFR-mutant NSCLC after progression on osimertinib). Dr. Patrick Forde, chairing the metastatic lung track, and Dr. Riyaz Shah both flagged the Presidential session, and Dr. Tom Newsom-Davis noted the KRASCENDO-1 topline press release already reported significant PFS and OS benefit, with the numbers held for Madrid. The Presidential wave lands as WCLC 2026 winds down — Seoul's SCLC ADC readouts, ARTEMIS-008 and TAISHAN-302, are still drawing commentary.
“1/4 🔥 #ESMO26 Lung Cancer Presidential Highlights 🇪🇸 Madrid | October 24–25, 2026 Three major Phase 3 lung cancer LBAs, each with potential to reshape treatment paradigms: 🎙️ LBA3 | DeLLphi-305 🎙️ LBA5 | KRASCENDO 1 🎙️ LBA6 | SAFFRON Three Phase 3 readouts to watch closely at #ESMO26 👀”
— @M_Torasawa · ESMO26 Presidential Lung · View post ↗
“Lots of lung data to look forward to at #ESMO26 We already know from press release that Krascendo-1 ➡️ significant PFS & OS benefit Details needed, of course, but next gen KRASi with greater activity than modest benefit of current options is very welcome #LCSM”
— @tnewsomdavis · KRASCENDO-1 Topline · View post ↗
“Three lung cancer phase 3 trials selected for presidential sessions at #ESMO26 ! I have been honoured to chair the metastatic lung track this year w 2 proffered paper & 2 rapid oral sessions & even more phase 3 trial results in EGFR lung cancer, radiation, & IO! #lcsm @myESMO”
— @FordePatrick · Presidential Sessions · View post ↗
“These 2 presentations at #ESMO26 could very well be practice changing or affirming. Have been avidly anticipating both. Some fundamental questions in the management of advanced NSCLC will be answered @BTOGORG”
— @DrRiyazShah · Practice-Changing Potential · View post ↗With the ESMO 2026 LBA titles released, breast oncologists are building their Madrid schedules. Dr. Yakup Ergün shared his top-10 breast cancer abstracts for the meeting — while noting no breast cancer study made the Presidential Symposia — and Dr. Paolo Tarantino pointed to the ADC wave taking over the program's late-breakers.
“My Top 10 Breast Cancer Abstracts #ESMO26 👇”
— @dr_yakupergun · Top-10 Breast Abstracts · View post ↗
“🌊 the ADC wave taking over #ESMO26”
— @PTarantinoMD · ADC Wave · View post ↗“There is no breast cancer or colorectal cancer study in the ESMO 2026 Presidential Symposia🧐”
— @dr_yakupergun · Presidential Absence · View post ↗📌 Amplified by @KolPulseAI
Oncologists across tumor types spent the day parsing the NEJM publication of NHS-Galleri — the first randomized trial of a multi-cancer early detection blood test — while the FDA's advisory panel voted on GRAIL's Galleri premarket approval application, ending 7–2–1 in favor of a non-binding endorsement (effectiveness itself split 6–4). Dr. Ilyas Sahin summarized the tension underlying that split vote: primary endpoint not met, with a secondary stage IV signal that grew by the third screening round — not enough, in his read, to support routine multicancer blood screening yet. Dr. Balazs Halmos weighed PATHFINDER 2, published in Nature Medicine, the same way. Separately, an 87% ORR with first-line anti-PD-1 plus bevacizumab in HER2-negative gastric/GEJ cancer drew attention.
“Can a blood test find cancers before they become advanced? 🩸 In the 142,250-person randomized NHS-Galleri trial (ages 50-77), annual multicancer blood testing was added to usual care. 🛑 Primary endpoint not met: no reduction in combined stage III/IV cancers.However, in a secondary analysis, stage IV cancers across the 12 prespecified cancer types were numerically 14% lower, with a larger difference by the third screening round. Interesting signal, but these results alone are not enough to support routine multicancer blood screening yet. And the timing is notable: an FDA advisory committee meets tomorrow to discuss and vote on Galleri’s premarket approval application. @NEJM *”
— @ilyassahinMD · NHS-Galleri Readout · View post ↗
“Holy Grail or holy sh..t? Very intriguing results from the PATHFINDER-2 trial with Galleri MCED test - trial does not reach its endpoint (of reducing n of 12 index st 3/4 cancers by 3 yrs) but still… notable separation of stage 4 cancer detection curves at 3 yrs+ so maybe endpoint was overoptimistic/too early? Despite very high specificity, low prevalence yields more false neg than true pos results so similar to scanxiety…. With MCED tests we will run risk of creating a new emotion: MSAD…”
— @BalazsHalmosMD · PATHFINDER 2 · View post ↗
“Most cancer deaths come from cancers we don't screen for. That's the pitch, and it isn't wrong.”
— @NeilVasan · Multi-Cancer Early Detection · View post ↗
“An 87% ORR in HER2-negative gastric cancer is the kind of number that stops you”
— @DrAllanPereira · Gastric Cancer Combination Therapy · View post ↗📌 Amplified by @KolPulseAI
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Two GU studies made the ESMO 2026 Presidential Symposium, and bladder cancer specialists are watching VOLGA. Dr. Kohji Takemura flagged the key question: whether neoadjuvant enfortumab vedotin plus checkpoint inhibition followed by adjuvant ICI alone — without adjuvant EV — can deliver, a design that would sidestep the cumulative neurotoxicity concern he raised with the current perioperative EV-pembrolizumab regimen. A new risk model for high-grade Ta/T1 non-muscle invasive bladder cancer (NMIBC) was developed to predict BCG-unresponsive disease or progression, using five predictors: T1 stage, residual HG/T1 at re-TURBT, multifocality, concomitant CIS, and WHO grade 3. Separately, a study in metastatic non-clear cell RCC found that patients younger than 45 had distinct metastatic patterns and shorter PFS (14.9 vs 30 months). There is also discussion around treatment for high-grade, T3N0M0 upper tract urothelial cancer in cisplatin-ineligible, ctDNA-negative patients.
“The ESMO 2026 LBA titles are now out. Two GU studies will be presented in the Presidential Symposium—and VOLGA is the one to watch! #ESMO26”
— @KohjiToncol · ESMO26 Presidential GU · View post ↗“A key point to watch in VOLGA: whether neoadjuvant EV + ICI followed by adjuvant ICI alone—without EV—can deliver positive results. The current perioperative EV + pembrolizumab regimen includes adjuvant EV, raising concerns about cumulative neurotoxicity. #ESMO26”
— @KohjiToncol · VOLGA Design Question · View post ↗
“Risk model to predict BCG-unresponsive disease or progression in HG Ta/T1 NMIBC (n=2,211; 13 centers). Five independent predictors: T1 stage, residual HG/T1 at re-TURBT, multifocality, concomitant CIS, and WHO grade 3. Outperforms EORTC and EAU 2021 stratification — with a free web calculator available.”
— @drenriquegrande · NMIBC Risk Model · View post ↗
“Does age matter in our patients with metastatic non-clear cell #RCC? Our new GSRGT study found distinct metastatic patterns and shorter PFS in patients <45 years (14.9 vs 30 months; P=.03).”
— @Anto_cigliola · non-clear cell RCC · View post ↗
“I wonder how you would treat a patient after nephro-uretectomy for a high grade, T3N0M0 upper tract urothelial cancer. The tumor is PD-L1+ve and ctDNA-ve. The pateint is not eligible for cisplatin.”
— @tompowles1 · UTUC Treatment Decision · View post ↗The International Myeloma Society meeting opened in Glasgow with a proposed consensus definition of cure in myeloma presented by Dr. Nikhil Munshi — “Myeloma is a Curable Malignancy,” as Dr. Malin Hultcrantz relayed from the session — while Dr. Meral Beksac shared Dr. Aurore Perrot's summary of the randomized evidence behind whether upfront transplant is still needed. Dr. Mohamad Mohty framed what comes next: CAR-T cells and bispecific antibodies entering head-to-head trials against transplant-based strategies in newly diagnosed myeloma, with no first-line randomized readouts yet — and, on maintenance, pointed to ENDURANCE as a reminder that toxicity is part of the efficacy equation. The CERVINO phase 3 readout of etentamig is expected in plenary this week.
“Now, CAR-T cells and bispecific antibodies are entering head-to-head trials against transplant-based strategies in newly diagnosed myeloma. The destination is not yet known, but the journey could redefine the standard of care. Exciting times at #IMS2026 in Glasgow! @TheIACH @COMyCongress”
— @Mohty_EBMT · T-Cell Redirection vs Transplant · View post ↗
“Myeloma is a Curable Malignancy - @NikhilMunshiMD @Myeloma_Society #mmsm #IMS2026”
— @MalinHultcrantz · Myeloma cure debate · View post ↗
“#IMS2026 the million usd question: do we need ASCT? @Myeloma_Society Aurore Perrot gave a great summary on current past & ongoing RCTs”
— @mbeksac56 · Do We Still Need ASCT? · View post ↗“Maintenance is a marathon, not a sprint. As we extend therapy to deepen and sustain disease control in myeloma, toxicity becomes part of the efficacy equation. ENDURANCE reminds us that indefinite maintenance may increase burdens such as fatigue, diarrhoea and neutropenia, even without an apparent increase in second primary malignancies. The future of maintenance is not only about how long we can treat, but how long patients can live well on treatment.”
— @Mohty_EBMT · Maintenance & ENDURANCE · View post ↗📌 Amplified by @KolPulseAI
A "How I Treat" feature highlights the use of MRD testing to personalize allogeneic HCT for adults with AML.
“How I Treat: MRD testing to personalize allogeneic HCT for adults with AML”
— @DrChrisHourigan · AML Treatment Strategy · View post ↗