🆙#ESMO26 Poster: #LCSM
🔥SHR-4849 (IDE849), an ADC Targeting Delta-Like Ligand 3 (DLL3), in Relapsed Small Cell Lung Carcinoma (SCLC) and Other Neuroendocrine Carcinomas (NECs): Long-Term Results From the Phase 1 Study
🎙️Dr. Haifeng Liu
🔢3815P
🎯SCLC ≥1.8mg/kg: ORR 68.3% (Confirmed 55.4%), DCR 94.1%
🎯Median PFS 6.8mo, 12-Mo OS 64.1%
🎯Brain Mets ORR 76.9%
🎯Other NECs ORR 47.4% (n=122; 8.7-Mo Median Follow-Up)
☑️NCT06443489
🔗 cslide.ctimeetingtech.com/es…
@OncoAlert @Larvol @myESMO @IASLC
STL Biotech retweeted
#ESMO26 is a wrap. A few thoughts.
It is a privilege to be an oncologist. To everyone who took the time to meet with me, lend their expertise or mentor me in some way: thank you. I am grateful. Also, to the patients who contributed their time, hope and lives to allow these studies to happen, thank you. This is what allows progress.
1. ESMO absolutely brought incredible advancements. So did China. This was the first global conference where the USA has clearly been dethroned as the de facto biomedical trial leader (5 of the 7 Presidential Symposium late-breakers focused on new drugs were Chinese developed). Chinese patients will be getting access to the latest biomedical advances, first.
2. The molecular era is here for KRAS. Expect it to come to early lines, in every tumor, fast. Expect sexy combos. (I am personally very excited about Genmab + Incyte's LGR5-EGFR + G12D but also think Verastem’s and RevMed’s G12D’s look great.)
3. Some advances look meaningful but are minor. PD1-VEGF beats PD1, but it wasn't compared to PD1 + VEGF. The benefit looks similar to adding bev (duh).
4. Cellular therapy is finally here for solid tumors. Get your systems ready now, it takes years to truly prepare. The 66% response rate for TezR (SL-28) across all-comer solid tumors blew my mind.
5. ADCs will hit CRC/GI quickly, and in a few years there will be many questions about sequencing. Please please please stop using the same payloads.
6. Medical education is more important than ever with how fast the field is moving. If anyone has advice on how @TheGutOncLab can disseminate information better (like the people at @OpenMedicineHQ and @OncoAlert do), please let me know.
Here's to next year. Already getting ready for @ASCO GI
@TheGutOncLab @Onco_Nexus
STL Biotech retweeted
Not enough people are screaming with excitement about how insanely good these numbers are! 82% ORR, with 100% 9 month PFS in 2 L MTAP del PDAC with ongoing responses at 12 months. Pure insanity! #precisionmedicine 🤌
Encouraging early results from Tango Therapeutics' vopimetostat combinations with daraxonrasib and zoldonrasib in PDAC, particularly the preservation of activity in later-line disease. #ESMO26
Daraxonrasib + vopimetostat: 81.8% confirmed ORR (18/22), including 85.7% (6/7) in 2L and 84.6% (11/13) in 3L, with 100% disease control. Nine-month PFS was estimated at 88.4% overall.
Zoldonrasib + vopimetostat: 54.2% confirmed ORR (19/35), including one CR.
Impressive early activity, but several questions deserve attention:
• Molecular context: Tango directed KRAS G12D patients toward zoldonrasib, while its daraxonrasib PDAC cohort was predominantly G12V/G12R, with no reported G12D. The FDA's exploratory daraxonrasib monotherapy analysis showed ORRs of 50% in G12V, 24% in G12D, and 7% in G12R. How much of the combination activity reflects molecular selection versus complementary PRMT5 inhibition? A response breakdown by mutation would be particularly informative, especially for G12R.
• Response maturity and patient accounting: At the August cutoff, daraxonrasib's 18/22 responses included 11 confirmed and seven awaiting confirmation. Tango subsequently confirmed all seven, bringing the confirmed ORR to 81.8%. But what happened to the seven additional treated PDAC patients excluded by the 14-week evaluability rule? Were their outcomes also updated? The confirmed 18/22 corresponds to 62.1% (18/29) using the all-treated denominator. Likewise, zoldonrasib's confirmed 19/35 corresponds to 48.7% (19/39), with four patients outside the efficacy analysis. These are fixed-numerator sensitivity calculations, not formally reported ITT/mITT ORRs. Updating response-confirmation status without providing corresponding follow-up for initially unevaluable patients leaves an important question unanswered.
• Phase 3 dose selection: Daraxonrasib's headline 81.8% ORR pools two dose levels, including three efficacy-evaluable patients at the higher vopimetostat dose. Yet the proposed Phase 3 regimen uses the lower dose. What is the confirmed ORR, response durability, and delivered dose intensity specifically at the proposed Phase 3 dose? And how reliably might activity observed predominantly in 2L/3L translate into the planned first-line population?
• Baseline fitness: ECOG 0 was 58.6% in the daraxonrasib cohort versus 33.3% with zoldonrasib. How much does this imbalance influence comparisons between the two combinations?
• Tolerability,➡️attenuation or redistribution @Aiims1742? PRMT5 inhibition may attenuate certain RAS-inhibitor toxicities through MAPK signaling. But does it genuinely reduce the overall toxicity burden, or merely redistribute it? At the proposed Phase 3 dose, Tango reported no Grade 3 rash, yet 40% Grade 3 treatment-related adverse events overall. Increasing vopimetostat produced three dose-limiting toxicities in two of four patients. Could selective attenuation of RAS-associated rash coexist with additional PRMT5-associated toxicity, without widening the therapeutic window? Matched-exposure comparisons would be particularly informative. The zoldonrasib combination's 38.5% nausea and vomiting rates reinforce the need to assess overall tolerability rather than isolated adverse events.
• Pharmacokinetics: Vopimetostat increased zoldonrasib exposure approximately 1.5–2.4-fold. How much of the observed activity reflects complementary biology versus increased inhibitor exposure?
• Dose intensity: With substantial interruptions and reductions, what proportion of the planned dose was actually delivered for each component over successive cycles? Were these modifications predominantly front-loaded or cumulative, and did patients maintain adequate exposure over time?
Well well well…
This was certainly my favorite RCC / kidney cancer presentation and heralding a significant shift in the RCC landscape!
45% response in heavily pretreated pts. Highly impressive!
Needs to move into frontline combinations! Congrats @montypal + colleagues
$PFE Wild to me that I spend a ridiculous amount of time looking at a variety of different therapeutic and competitive landscapes to invest in pipeline drugs and Pfizer hardly ever comes up.
What are they doing over there
Which of these ~20B biotechs is most likely to join the lg/mega cap biotech mt Rushmore (GILD, VRTX, AMGN, REGN)
51%$GMAB
8%$BNTX
18%$INCY
22%$ALNY
267 votes • 1 hours STL Biotech retweeted
Shrinkage of brain metastasis in a patient with MTAP-deficient lung cancer treated with BeOne's PRMT5 inhibitor.
A reason for optimism that this class may have activity in glioblastoma (~40% MTAP-deficient)?
STL Biotech retweeted
$IDYA •17.4-month median OS in 2L SCLC (n=51) and 14.7-month median OS in 2L + ≥3L SCLC (n=101)
•72.5% (37/51) ORR and 60.8% (31/51) cORR in 2L SCLC with 6.9-month median PFS; 68.3% (69/101) ORR and 54.5% (55/101) cORR in 2L + ≥3L SCLC with 6.8-month median PFS
•76.9% (20/26) ORR and 65.4% (17/26) cORR in SCLC patients with brain metastases
•Efficacy observed in NECs, with 52.6% (10/19) ORR, 36.8% (7/19) cORR, 7.0-month median PFS and an 82.4% nine-month OS rate
•Grade ≥3 TRAE of 33.3% at the 2.4 mg/kg expansion dose. 2.5% treatment-related discontinuation rate and 0.8% Grade ≥3 ILD rate observed across the study (n=122)
•In IDEAYA's separate IDE849 global clinical study at the 2.4 mg/kg and 3.5 mg/kg expansion doses a Grade ≥3 TRAE rate of 5% (1/20) and 22.2% (4/18) have been observed, respectively
•Following successful Type C meetings with the U.S. FDA, IDEAYA is targeting to initiate two Phase 3 registrational trials with IDE849 in ES-SCLC and NEC. Evaluation of a potential 1L ES-SCLC Phase 3 study design is ongoing with continued data generation from several clinical combinations
$IDYA IDE849 (SHR-4849) DLL3 TOP1 ADC Updated Phase 1 Results at ESMO 2026 Demonstrates Promising Anti-Tumor Activity and Preliminary Overall Survival Results in Relapsed Small Cell Lung Cancer and Neuroendocrine Carcinomas - Oct 23, 2026 media.ideayabio.com/2026-10-…
Lmao, how are docs going to even pick drugs for UC patients in a few years. Is there a more crowded/competitive indication than IBD?
investors.gilead.com/news/ne…
STL Biotech retweeted
By my count, there are 14 clinical trials testing drugs with totally new targets at ESMO.
These include:
The first inhibitor of the (previously undruggable) β-catenin-TCF interaction — Parabalis Medicines.
The first clinical PIP4K2C degrader, triggers metabolic stress — Larkspur Bioscience.
The first clinical TNFR2-targeting (Treg-depleting) antibody, a new immunotherapy strategy — BioInvent.
Full analysis here, just in time for tomorrow! breakingground.substack.com/…
Re: $ABVX
More attractive than the *best* drug in IBD, lg pharma may prefer a *decent* drug with an IP estate they can manage for 15 years and perhaps a somewhat more predictable tail value/% of sales retained after biosimilar entrance.
Explains "go it alone"conversation
My (I'm sure imperfect) database of the last 20 years of biotech acquisitons' average estimated remaining market exclusivity at deal announcement has mean of 12.5 yrs and median of 13 years, shorter first decade, longer last decade as deals have moved earlier-stage.




























