Timothée Olivier, MD · @Timothee_MD“Adagrasib was just withdrawn by the @FDA in metastatic colorectal cancer based on the negative results in KRYSTAL-10 "A waterfall plot can look impressive, and high response rates can create enthusiasm, but they should not be confused with proven clinical benefit." From Sahar van Waalwijk, new guest post in https://t.co/P3NUOebqBF !”
View post ↗Read the full KRYSTAL-10 withdrawal record on KOL Pulse →Anticipation is high for the upcoming WCLC26 conference, where data from the REZILIENT-3 trial of zipalertinib is expected to inform the standard of care for EGFR exon 20 NSCLC, following recent data for sunvozertinib. Key questions in SCLC will also be addressed, including the role of Prophylactic Cranial Irradiation (PCI) versus MRI and the potential for two B7-H3 ADCs to replace topotecan as a comparator. Additionally, the SARON trial will present data on consolidation radiotherapy for synchronous oligometastatic NSCLC at ESMO26. Also circled on the program: detailed overall survival results from HARMONi-2, comparing ivonescimab with pembrolizumab in first-line PD-L1-positive advanced NSCLC, set for presentation at WCLC26 (OA14.01, September 15).
“Nine trials in two Presidential Symposia will answer questions we have been arguing about for a decade: whether PCI survives the MRI era in SCLC, whether topotecan is finished as a comparator once two B7-H3 ADCs report side by side, and whether exon 20 gets one standard or two.”
— @GlopesMd · WCLC26 Key Debates · View post ↗
“At ASCO26 we saw 1L Sunvozertinib /WU-KONG 28) data, perhaps similar in activity to chemo+amivantamab (PAPILLON), different side effects Will Zipalertinib be better, equivalent or worse?”
— @tnewsomdavis · EGFR Exon 20 NSCLC · View post ↗📌 Amplified by @KolPulseAI
“A must-read for every SCLC-warrior exemplifying that the combination of #TCEs and #ADC holds promise for deep and durable responses in ES-SCLC”
— @g_mountzios · Novel Therapies in SCLC · View post ↗📌 Amplified by @KolPulseAI
“The detailed OS results from HARMONi-2, comparing ivonescimab with pembrolizumab in first-line PD-L1-positive advanced NSCLC, will be presented at #WCLC26.”
— @M_Torasawa · HARMONi-2 OS at WCLC26 · View post ↗The FDA granted accelerated approval to the oral SERD camizestrant, combined with a CDK4/6 inhibitor, for patients with HR+, HER2- metastatic breast cancer upon detection of an ESR1 mutation while on a first-line aromatase inhibitor and CDK4/6 inhibitor, based on the SERENA-6 trial. The FDA approval, which followed a 3-6 negative ODAC vote, introduces a strategy of switching therapy based on molecular resistance detected in ctDNA before radiographic progression. Also circulating are new ASCO surveillance guidelines advising against routine tumor markers, metastatic imaging, and ctDNA for survivors, and NCCN 2026 guidelines on axillary management.
“switching therapy when an ESR1 mutation appears in ctDNA, before scans show progression. This is resistance defined, drugged, and tracked at the bedside.”
— @NeilVasan · Camizestrant approval strategy · View post ↗📌 Amplified by @KolPulseAI
“On April 30, ODAC voted 3-6 against.”
— @DrChoueiri · Camizestrant ODAC vote · View post ↗
“Not every breast cancer survivor needs the same intensity of follow-up. Risk-stratify. De-escalate when appropriate. Intensify when risk is high.”
— @K_Yadavir · ASCO surveillance guidelines · View post ↗
“• 1–2 positive SLNs + appropriate BCS/RT → no ALND”
— @dr_yakupergun · NCCN axillary guidelines · View post ↗The FDA has accepted Bristol Myers Squibb's voluntary withdrawal of the accelerated approval of adagrasib plus cetuximab for previously treated KRAS G12C-mutated colorectal cancer. This action follows the failure of the confirmatory Phase III KRYSTAL-10 trial to meet its primary endpoints of progression-free survival (7.5 vs 8.1 months) and overall survival (21.6 vs 21.7 months) versus standard chemotherapy in the second-line setting. Despite the negative trial, some physicians noted the combination's higher response rate in KRYSTAL-10 (47% vs 16%).
“And just like that, adagrasib + cetuximab is no longer FDA approved for KRAS G12C colorectal cancer.”
— @GIMedOnc · Adagrasib approval withdrawal · View post ↗📌 Amplified by @KolPulseAI
“Anyone celebrating this should look themselves in the mirror; this is a tool that has just been removed from our arsenal. However, the FDA did exactly what the system is designed to do; pull back if the Ph III doesnt pan out after accelerated approval.”
— @GIMedOnc · Physician perspective on FDA action · View post ↗📌 Amplified by @KolPulseAI
Track oncology’s top KOLs in your specialty
Create a free account, pick the tumor types you cover, and go beyond the tweet — the intelligence pharma teams use to map influence and prepare for engagement:
- ✓Enhanced KOL profiles
- ✓Pharma influence & potential advisory-board patterns
- ✓2025 Open Payments financial analysis
- ✓Social-media sentiment & trend signals
The PSMAddition trial of Pluvicto plus an ARPI in PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC) showed a radiographic progression-free survival HR of 0.72. Separately, a prospective trial of embolization plus cryoablation for cT1b renal cell carcinoma (RCC) demonstrated a 96% complete response and 100% local control. Research in high-risk T1 bladder cancer identified an immune-infiltrated molecular subtype with the best response to BCG.
“✅ 96% complete response ✅ 100% local control ✅ only 1 serious AE ✅ no local recurrence at 14.1 months ✅ No detriment to renal function”
— @ajgunnmd · RCC Embolization + Cryoablation · View post ↗
“• rPFS HR 0.72 (0.58–0.90); medians NR both arms”
— @oncologytube · PSMAddition Trial · View post ↗
“profiling 106 high-risk T1 bladder cancers revealed 4 molecular subtypes. 💡An immune-infiltrated subtype had the best BCG response..”
— @LauraBukavinaMD · Bladder Cancer Subtypes · View post ↗The FDA's August 13 accelerated approval of iberdomide (Zenbexus) plus daratumumab and dexamethasone for relapsed/refractory multiple myeloma, granted on an MRD-negativity endpoint in the EXCALIBER-RRMM trial, is being highlighted as a significant development for accelerating drug access. Separately, a systematic review and meta-analysis on AL amyloidosis diagnostics found fat pad biopsy and surgical/punch biopsy have similar sensitivities (0.80 and 0.77, respectively); one study included in the analysis that used both methods yielded a sensitivity of 0.89. A paper on the efficacy and safety of CAR T-cell therapy for plasma cell leukemia was also shared.
“This kind of forward thinking already happening in hematologic cancers as well with recent FDA approval based on MRD-negativity endpoint in myeloma. As long as the surrogate is reliably associated with meaningful clinical endpoints, it gets new drugs to patients faster!”
— @n8pennell · MRD as a regulatory endpoint · View post ↗📌 Amplified by @KolPulseAI
“#Myeloma Paper of the Day: Systematic review & meta-analysis of diagnostic accuracy of fat pad & BM sampling for AL #amyloidosis finds fat pad & surgical/punch bx w/ similar sensitivity (0.80 & 0.77, respectively); one study w/ both yielded 0.89: https://t.co/q1E2yFsimg.”
— @Myeloma_Doc · AL amyloidosis diagnostics · View post ↗
“Some people contribute to a field. A rare few define it, and, through their generosity, make it possible for generations of others to find their own path within it. Dr. Robert “Bob” Kyle was one of those rare individuals.”
— @DrOlaLandgren · Tribute to Dr. Robert Kyle · View post ↗The phase 2 PARADIGM trial showed superior event-free survival (EFS) for azacitidine-venetoclax over intensive chemotherapy in fit, transplant-eligible adults with AML (14.5 vs 6.2 mo, HR 0.57), though overall survival was similar. This result, along with data from the Lu et al trial, is prompting discussion on expanding venetoclax-based induction to fit patients with intermediate or adverse risk, FLT3-wildtype AML. A separate subgroup analysis of a pivotal trial detailed the efficacy of first-line tagraxofusp in blastic plasmacytoid dendritic cell neoplasm (BPDCN) with prior or concomitant hematologic malignancy.
“Bottom line: two independent prospective trials (PARADIGM, Lu et al) plus molecularly-enriched retrospective data now support VEN-based induction as a reasonable option in fit, transplant eligible, intermediate or adverse risk, FLT3 wildtype AML.”
— @TalhaBadarMD · Aza-Ven vs. IC in fit AML · View post ↗
“Azacitidine–Venetoclax or 7+3 Induction for AML -- 7+3 isn't quite dead yet!”
— @MikkaelSekeres · Aza-Ven vs. IC in fit AML · View post ↗
“Efficacy of first-line tagraxofusp in blastic plasmacytoid dendritic cell neoplasm with prior or concomitant hematologic malignancy: subgroup analysis of a pivotal trial”
— @mtmdphd · Tagraxofusp in BPDCN · View post ↗