Physician discussion, October 23–25

Physician posts on X, October 23–25.

Also discussed: MASTERPLAN (posts), CheckMate 8HW (posts), AMPLIFY-7P (posts), and telisotuzumab adizutecan plus bevacizumab and CLARITY-Gastric01, both covered below.

1. SANO: active surveillance vs esophagectomy after clinical complete response

Phase 3 stepped-wedge, cluster-randomized trial, N=309, after neoadjuvant chemoradiotherapy (41.4 Gy). 5-year OS 50% with active surveillance vs 54% with surgery, HR 1.17 (95% CI 0.77–1.77), not significantly different; the confidence interval is wide and equivalence was not formally shown. DFS HR 1.39 (0.94–2.06). 5-year distant metastases 46% vs 29%, P<.01. 85 of 198 patients (43%) under surveillance were spared esophagectomy; the slide labels this figure hypothetical. (ESMO 2026 LBA78 abstract and slides, Sanjiv Gangaram-Panday; median follow-up 76 months) SANO tests a treatment strategy, not a drug.

Physicians split on whether the trial supports offering surveillance. Points raised: the distant-metastasis rate, that a non-significant OS difference does not establish non-inferiority, and the 41.4 Gy dose.

2. HERIZON-GEA-01: zanidatamab ± tislelizumab in first-line HER2+ gastroesophageal adenocarcinoma

Phase 3, N=914: zanidatamab + chemotherapy, with or without tislelizumab, vs trastuzumab + chemotherapy. At the second interim OS analysis, zanidatamab + chemotherapy improved OS vs trastuzumab + chemotherapy: median 22.9 vs 19.6 months, HR 0.76 (95% CI 0.62–0.93), P=0.0088; 36-month OS 31.5% vs 22.9%. The triplet vs trastuzumab + chemotherapy: median OS 27.0 vs 19.6 months, HR 0.65 (0.52–0.80), a descriptive analysis because significance was already met at the first interim; 36-month OS 39.8%. Triplet vs doublet: HR 0.81 (0.65–1.00), P=0.0502, not statistically significant. (ESMO 2026 LBA79 slides, Kohei Shitara; second interim analysis, data cutoff Jul 15, 2026; median follow-up 35.3 months) The safety profile was consistent with the first interim analysis. (LBA79 safety slide) FDA approved on August 25, 2026: Ziihera + Tevimbra + chemotherapy for HER2 IHC 3+ or IHC 2+/ISH+ disease, and Ziihera + chemotherapy for IHC 3+. (KOL Pulse HERIZON-GEA-01 page)

The doublet’s OS result was not debated. The debate was whether to add tislelizumab, given the P=0.0502 comparison and added toxicity.

Doublet or triplet?

Nicholas Hornstein @GIMedOnc

GI medical oncologist, Northwell · Oct 23

HERIZON-GEA-01 second OS interim at #ESMO26, and I'm a triplet believer. In January I wondered if tislelizumab was necessary. With 35 months of follow-up, my answer is yes. 914 patients, 1L HER2+ GEA, randomized 1:1:1 to zani + chemo ± tislelizumab vs trastuzumab + chemo. Median OS
• Zani + chemo + tisle: 27.0 mo
• Zani + chemo: 22.9 mo
• Tras + chemo: 19.6 mo 3-year OS: 39.8% vs 31.5% vs 22.9% The doublet now has its own OS win over trastuzumab (HR 0.76, 95% CI 0.62–0.93, p=0.0088). The triplet vs trastuzumab got better with time (HR 0.72 at IA1, now 0.65). Triplet vs doublet: HR 0.81 (95% CI 0.65–1.00), p=0.0502. Yes, it technically misses. But 4 more months of median OS is clinically meaningful in metastatic gastric cancer. Patients also stayed on the triplet longer (~47 vs ~30 weeks), with no new safety signal. Takeaway: zani + chemo + tisle is my 1L default for HER2+ GEA. Bring on the bispecifics 🔥 @OncoAlert @TheGutOncLab @OncoAlert

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Yakup Ergün @dr_yakupergun

medical oncologist · Oct 23

#ESMO26 | HERIZON-GEA-01 – Updated OS Her2 positive gastric/ge cancer At 35.3 months of follow-up, zanidatamab + CT now shows a significant OS benefit over trastuzumab + CT: 22.9 vs 19.6 months (HR 0.76; p=0.0088). With the addition of tislelizumab, median OS increased to 27 months, but the additional benefit was statistically borderline (HR 0.81; p=0.0502). Considering toxicity, we need to carefully analyze which patients should receive the triplet regimen.

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Nurullah İlhan,MD @drnurullahilhan

medical oncologist, Istanbul · Oct 25

HERIZON-GEA-01 raises a treatment-selection question in 1L HER2+ advanced gastroesophageal adenocarcinoma. Zanidatamab + chemo improved OS vs trastuzumab + chemo: 22.9 vs 19.6 months; HR 0.76; P=0.0088. The tislelizumab triplet also sustained its OS benefit vs trastuzumab + chemo. But the direct comparison matters: Adding tislelizumab to zanidatamab + chemo gave OS of 27.0 vs 22.9 months; HR 0.81; P=0.0502 — not statistically significant. This does not establish equivalence between doublet and triplet. Who gains enough from adding immunotherapy to justify the extra treatment—and can biomarkers help us identify them? @KoheiShitara @YJanjigianMD @myESMO @OncoAlert #HERIZONGEA01 #ESMO26 #GICSM

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3. COMPANION-002: tovecimig + paclitaxel in previously treated biliary tract cancer

Phase 2/3: tovecimig, a DLL4×VEGF-A bispecific antibody, plus paclitaxel vs paclitaxel alone after prior therapy for advanced biliary tract cancer, presented by Nilofer Azad. The trial met its primary endpoint of response rate and improved PFS. OS did not differ, and the presented slide describes the OS analysis as confounded by crossover from the paclitaxel arm. Tovecimig is investigational.

An investigator on the trial highlighted response and PFS. Others pointed to the toxicity, the crossover, and first-line testing.

Response and PFS vs OS and toxicity

ilyas sahin, MD @ilyassahinMD

GI medical oncologist, Mass General; COMPANION-002 investigator · Oct 24

Excited to see our COMPANION-002 trial published in JCO and presented at #ESMO26! Treatment options remain limited for advanced biliary tract cancer after first-line therapy, especially without targetable mutations. Tovecimig + paclitaxel vs paclitaxel alone: • Tumor response (ORR): 18% vs 5.3% • Time without progression (median PFS): 4.7 vs 2.6 months (HR 0.44) Proud to have contributed to this multicenter trial!

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Arndt Vogel @ArndtVogel

liver cancer and precision oncology, Princess Margaret / MHH · Oct 24

A randomized trial of paclitaxel ± tovecimig in previously treated patients with advanced biliary tract cancer #ESMO26 #ESMOAmbassadors 👉 ORR: 18 vs 5.3% 👉 mPFS: 4.7 vs 2.6 mo 👉 mOS: 8.9 vs 9.4 mo 🧐Active drug, but no OS benefit in 2nd line, could be explored in 1L @myESMO @ASCO

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Mario Balsa @MarioBalsaMD

medical oncologist, Hospital Clínic Barcelona · Oct 24

Signal in previously treated biliary tract cancer at #ESMO26: Tovecimig + paclitaxel improves ORR (17% vs 5%) and PFS (HR 0.44)…but with substantial toxicity, and OS remains uninterpretable given 54% crossover 🤷🏻‍♂️ @OncoAlert 4Sight is already dissecting the abstracts worth watching! 👀 @OncoReporte @_SEOM @myESMO

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Grainne O'Kane @graokane

medical oncologist, pancreatic and hepatobiliary cancers · Oct 24

Paclitaxel +\-tovecimig: COMPANION-002 ph2/3 ➡️prev treated #BTC wo actionable alterations ➡️ORR 17.1 v5.3%; DCR 62 v 37% ➡️mPFS 4.7 v 2.6mths - benefits seen at PFS2 noting crossover ➡️OS not sig but nb crossover @myESMO #ESMO26 @OncoAlert https://t.co/eeR74Ehqed

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4. G-HOPE-001: arcotatug tavatecan in CLDN18.2-positive gastric/GEJ cancer, third line and later

Phase 3, China and Japan: arcotatug tavatecan (IBI343), a CLDN18.2-directed antibody-drug conjugate, vs treatment of physician’s choice after at least two prior lines, presented by Kohei Shitara. PFS and OS both improved; the OS result was reported at the second interim analysis. Physicians quoted figures from two analyses, the abstract’s first interim and the updated second interim in the presentation, so the numbers differ between posts. Arcotatug tavatecan is not FDA approved.

Physicians called it a new option after two lines. Open questions: OS maturity, patients previously treated with zolbetuximab, and the lack of a Western cohort.

5. ACTICCA-1: adjuvant gemcitabine-cisplatin vs capecitabine in resected biliary tract cancer

Phase 3, presented by Henning Wege. The primary DFS endpoint was not met. OS was numerically longer with gemcitabine-cisplatin but not statistically significant, and toxicity was higher.

Physicians agreed it does not change the standard. They differed on whether gemcitabine-cisplatin is an option for selected patients.

6. RASolute 302: daraxonrasib by RAS genotype in previously treated pancreatic cancer

Phase 3, N=500. Primary results: median OS 13.2 vs 6.7 months with daraxonrasib vs chemotherapy, HR 0.40 (95% CI 0.30–0.53), overall population. (ASCO 2026 LBA5 / NEJM; data cutoff Feb 10, 2026) At ESMO 2026, Zev A. Wainberg presented subgroup analyses from the same data cutoff. OS HR by RAS genotype: G12D 0.49 (0.33–0.74), G12V 0.32 (0.19–0.54), G12R 0.61 (0.29–1.30), Q61 0.37 (0.09–1.44), no RAS mutation identified 0.43 (0.09–1.98). The G12R, Q61 and no-mutation groups were small (30 vs 31, 11 vs 11 and 9 vs 7 patients) and their confidence intervals cross 1. ORR by BICR in G12R was 7% vs 14%. (ESMO 2026 LBA82 slides; subgroup HRs from an unstratified Cox model; median follow-up 8.5 months) FDA approved on August 26, 2026 as Rasonque for metastatic pancreatic adenocarcinoma after at least one prior systemic therapy, or in patients who are not candidates for multiagent therapy. The label does not restrict use by RAS status. (KOL Pulse RASolute 302 page)

Physicians agreed on the overall benefit. The question was RAS G12R.

7. KEYNOTE-975: pembrolizumab with definitive chemoradiotherapy in esophageal cancer

Phase 3: pembrolizumab or placebo with definitive chemoradiotherapy in unresectable esophageal or GEJ cancer, presented by Manish Shah. EFS was not improved in PD-L1 CPS ≥10 tumors, and OS was not formally tested. Pembrolizumab is not approved with definitive chemoradiotherapy for esophageal cancer.

Physicians agreed the trial was negative. Discussion turned to radiation dose, timing of immunotherapy relative to radiation, and toxicity.

8. HARMONi-GI1: ivonescimab + gemcitabine-cisplatin vs durvalumab + gemcitabine-cisplatin in first-line biliary tract cancer

Phase 3 (LBA8), presented by Jian Zhou on October 25 in Presidential Symposium II, with James J. Harding as invited discussant. The comparator, durvalumab plus gemcitabine-cisplatin, is the FDA-approved first-line standard from TOPAZ-1. Physicians reported a statistically significant OS improvement, with gains in PFS and response rate. Ivonescimab, a PD-1×VEGF bispecific antibody, is investigational in the US; its first FDA application, in EGFR-mutant lung cancer, is under review. (KOL Pulse HARMONi-A page)

Physicians called the comparator appropriate and the OS result meaningful. Open questions: VEGF-related toxicity, a China-only population and short follow-up.

After the presentation, physicians called the survival gain meaningful, noted the added toxicity and asked whether the result applies outside China.

Yakup Ergün asked about subsequent therapy, meaning treatment given after the trial treatment, as reported on the presented subsequent anti-tumor therapy slide (Jian Zhou, LBA8).

9. PRABITAS: biweekly vs conventional trifluridine-tipiracil + bevacizumab in refractory colorectal cancer

Pragmatic, non-inferiority Phase 3 trial from Japan, presented by Hiroya Taniguchi and published in The Lancet. The biweekly (14-day) schedule was compared with the conventional 28-day schedule. OS met non-inferiority, with less grade ≥3 neutropenia on the biweekly schedule. Trifluridine-tipiracil plus bevacizumab is FDA approved for previously treated metastatic colorectal cancer; PRABITAS tested the dosing schedule, not a new drug.

Physicians agreed on the schedule. The debate was why it took a randomized trial, after earlier real-world and Phase 2 data.

A new standard schedule, or overdue?

Nobuhiro Shibata MD, PhD @shibanob

medical oncologist, Kansai Medical University; PRABITAS co-author · Oct 24

#ESMO26 LBA31 PRABITAS Phase 3 Trial A pragmatic phase 3 non-inferiority trial comparing biweekly vs conventional FTD/TPI + bevacizumab in refractory mCRC. Efficacy:
• OS: 11.3 vs 10.3 mo (HR 0.93, 95% CI 0.80–1.08)
• PFS: 3.9 vs 3.9 mo (HR 0.93, 95% CI 0.81–1.06) Safety:
• Grade ≥3 neutropenia: 13% vs 39%
• Febrile neutropenia: 1% vs 5%
 Biweekly FTD/TPI + bevacizumab demonstrated non-inferior OS with reduced toxicity compared with the conventional schedule. Our institution, Kansai Medical University Hospital, participated in this study. I am pleased to have contributed as a co-author. Simultaneously published in The Lancet! https://t.co/O0yd2m1dqc #PRABITAS #mCRC #ColorectalCancer
@OncoAlert

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Sharlene Gill, MD, MPH, MBA, FASCO @GillSharlene

GI medical oncologist, University of British Columbia · Oct 24

Shout out to the PRABITAS study team 🇯🇵 for providing Level 1 evidence to confirm earlier RWE (with a pragmatic design and no industry funding!) ➡️ biweekly TAS102 should be the new standard for SUNLIGHT ➡️Simultaneous publication in @TheLancet https://t.co/o6Vor5Ms9a ➡️Great discussion by @KaiKeenShiu #ESMO26 @myESMO

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Nicholas Hornstein @GIMedOnc

GI medical oncologist, Northwell · Oct 25

PRABITAS: PIII biweekly vs conventional TAS-102 + bev in refractory mCRC 🇯🇵, presented at #ESMO26. Yay for confirmation. But everyone should have been doing this since the OG publications (and certainly after @CathyEngMD published). The SUNLIGHT schedule (TAS-102 days 1–5 and 8–12, bev days 1 and 15, every 28 days) works, but the neutropenia is savage at almost 50% G3-4 on SUNLIGHT. PRABITAS has the same dose but spreads it out a littttttle more: TAS-102 days 1–5 + 15-19 and bev every 14 days. 970 patients, dosing at physician discretion. The primary endpoint was OS with an NI margin of 1.25. OS 11.3 vs 10.3 mo, HR 0.93 (95% CI 0.80–1.08). Non-inferior, and the curves are the same. Massive tox reduction, consistent with prior data. This shouldn't surprise anyone. Cathy Eng's group published this schedule in 2025: 16% grade ≥3 neutropenia, no febrile neutropenia, no G-CSF. The Japanese phase 2 data go back to 2020. Do we really always need randomized data to change practice? Do patients deserve to wait for 5+ years? Asking for a friend. @OncoAlert @TheGutOncLab @Onco_Nexus

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Dr. Cathy Eng @CathyEngMD

GI medical oncologist, Vanderbilt-Ingram · Oct 24

PRABITAS phase III trial pragmatic trial enrolled 972 pts in 17M evaluating the schedule of TAS-102 + bev (2 weeks on/2 weeks off) vs. (1 week on/1 week off) which validates non-inferiority and less dose reductions validating our RWD approach in the US. #colorectal #cancer #ESMO2026 @OncoAlert

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10. IROCAS: adjuvant mFOLFIRINOX vs mFOLFOX6 in high-risk stage III colon cancer

Phase 3 (LBA29) in resected T4 and/or N2 colon cancer, presented today by Jaafar Bennouna with Jeffrey Meyerhardt as invited discussant, and published concurrently in Annals of Oncology. Adding irinotecan to adjuvant oxaliplatin-based chemotherapy did not improve 3-year DFS, the primary endpoint, and OS did not differ significantly. Diarrhea was more frequent with mFOLFIRINOX. All drugs in both regimens are approved; IROCAS tested whether intensifying the adjuvant regimen helps.

Physicians agreed the trial answers the adjuvant irinotecan question. Discussion moved to what to try next in high-risk and ctDNA-positive stage III disease.

11. AZUR-1: dostarlimab alone in dMMR/MSI-H locally advanced rectal cancer

Global, single-arm Phase 2, N=154: dostarlimab for 9 cycles (6 months) in untreated stage II/III dMMR/MSI-H rectal cancer, presented today by Andrea Cercek (LBA87) with David Tougeron as invited discussant, and published concurrently in Annals of Oncology. The primary endpoint, cCR12 (clinical complete response sustained for 12 months) by independent central review, was 47% (54 of 116 evaluable patients). By investigator assessment, cCR12 was 68% (95% CI 60–76) of 144 evaluable patients. 110 of 154 patients (71%) were treated with dostarlimab alone, had no further treatment and had no disease progression at data cutoff; median follow-up was 26.3 months. (FDA approval notice, Oct 19, 2026, via KOL Pulse AZUR-1 page; data cutoff as reported by FDA) The central-review and investigator figures use different evaluable populations; the presented slide shows that investigators recorded complete responses earlier than central review. FDA granted accelerated approval on October 19, 2026: Jemperli (dostarlimab) for adults with stage II/III dMMR/MSI-H locally advanced rectal cancer, as determined by an FDA-authorized test. (KOL Pulse AZUR-1 page)

Physicians called dostarlimab alone a new standard for these patients. The main caveat raised was the gap between investigator and central-review results.

Also new: CLARITY-Gastric01 and telisotuzumab adizutecan

CLARITY-Gastric01: sonesitatug vedotin in CLDN18.2-positive gastroesophageal cancer, second line and later

Phase 3 (LBA7): sonesitatug vedotin, a CLDN18.2-directed antibody-drug conjugate, vs investigator’s choice, presented by Rui-Hua Xu on October 25 in Presidential Symposium II, with Salah-Eddin Al-Batran as invited discussant. Physicians reported an OS improvement, while PFS did not meet its significance threshold. Sonesitatug vedotin is investigational.

After the presentation, physicians welcomed the OS result in later lines. Open questions were the missed PFS endpoint in the overall population, the role in second line and use after zolbetuximab.

Telisotuzumab adizutecan + bevacizumab in refractory metastatic colorectal cancer

Long-term follow-up of a randomized Phase 1 comparison (791RO): telisotuzumab adizutecan (Temab-A, ABBV-400), a c-Met-directed antibody-drug conjugate, plus bevacizumab vs trifluridine-tipiracil plus bevacizumab in third-line or later disease. Michael Cecchini presented it on October 24 in the lower GI rapid oral session; Lisa Salvatore discussed it. The paper was published concurrently in Annals of Oncology. Efficacy favored Temab-A plus bevacizumab, with hematologic toxicity the main concern. A Phase 3 trial is ongoing, and Temab-A is investigational.

KOL Voices: GI cancer leaderboard

The top physicians on the ESMO 2026 KOL leaderboard, GI tab. One line from each, verbatim, with the trial it is about.

1. 1
   Nicholas Hornstein GI medical oncologist, Northwell · 51.6K impressions, 22 posts

   on PRABITAS → “Do we really always need randomized data to change practice?”
2. 2
   MV Chandrakanth medical oncologist, Narayana Health Kolkata · 48.7K impressions, 63 posts

   on SANO → “Surgery when needed — NOT surgery never!”
3. 3
   Nieves Martinez Lago MD PhD GI medical oncologist · 44.1K impressions, 38 posts

   on PRABITAS → “💡 Same survival, less toxicity!”
4. 4
   Jeff Ryckman radiation oncologist · 34.2K impressions, 32 posts

   on KEYNOTE-975 → “Another reason not to assume IO helps every CRT backbone.”
5. 5
   Arndt Vogel liver cancer and precision oncology, Princess Margaret / MHH · 31.8K impressions, 28 posts

   on COMPANION-002 → “Active drug, but no OS benefit in 2nd line, could be explored in 1L”
6. 6
   Anirban Maitra GI pathologist and pancreatic cancer researcher · 31.2K impressions, 5 posts

   on Daraxonrasib + vopimetostat (Tango) study “Reduced toxicity data is particularly important as a lower Daraxonrasib dose can be used.”
7. 7
   Angela Lamarca HPB and NET medical oncologist · 22.0K impressions, 42 posts

   on COMPANION-002 → “👉Development continues”
8. 8
   Daisuke Kotani, MD, Ph.D 小谷 大輔 GI medical oncologist, National Cancer Center Hospital East · 21.7K impressions, 16 posts

   on SANO → “Despite no significant OS or DFS differences, the wide CIs and significantly higher distant mets rate highlight important challenges for implementing active surveillance in clinical practice.”
9. 9
   Shankar Siva radiation oncologist, Peter MacCallum Cancer Centre · 20.2K impressions, 9 posts

   on MASTERPLAN → “Better efficacy without added harm.”
10. 10
    Erman Akkus medical oncologist · 17.4K impressions, 7 posts

    on HARMONi-GI1 → “mOS: 14.9 vs. 12.1 months; HR 0.75, 95% CI 0.61-0.92, P = 0.0031”

What’s yet to come: GI sessions on October 26–27

Times are Madrid time. Presidential Symposium III (October 26) has no GI abstracts.

FAQ

Which GI cancer trials did physicians discuss most at ESMO 2026?

By physician posts on X on October 23-25, the top GI trials were SANO, HERIZON-GEA-01, COMPANION-002, G-HOPE-001, ACTICCA-1, RASolute 302, KEYNOTE-975, HARMONi-GI1, PRABITAS, IROCAS and AZUR-1.

What did HERIZON-GEA-01 show at ESMO 2026?

At the second interim analysis (ESMO 2026 LBA79, data cutoff July 15, 2026), zanidatamab plus chemotherapy improved OS vs trastuzumab plus chemotherapy: 22.9 vs 19.6 months, HR 0.76 (95% CI 0.62-0.93), P=0.0088. Adding tislelizumab vs zanidatamab plus chemotherapy: HR 0.81, P=0.0502, not statistically significant. Both regimens have been FDA approved since August 25, 2026, with different HER2 criteria.

Does SANO show active surveillance is as good as surgery?

SANO found no statistically significant difference in 5-year OS (50% vs 54%, HR 1.17, 95% CI 0.77-1.77), but distant metastases were higher with surveillance (46% vs 29%). Equivalence was not formally shown, and physicians on X disagreed on whether to offer surveillance.

What was new for RASolute 302 at ESMO 2026?

Subgroup analyses (LBA82) showed OS hazard ratios below 1 across RAS genotypes, with small subgroups such as G12R (HR 0.61, 95% CI 0.29-1.30) having wide confidence intervals. Daraxonrasib (Rasonque) has been FDA approved since August 26, 2026 without a RAS-status restriction.

What did AZUR-1 show at ESMO 2026?

In 154 patients with untreated stage II/III dMMR/MSI-H rectal cancer given dostarlimab alone, cCR12 by independent central review (the primary endpoint) was 47% (54/116), and 68% by investigator assessment in 144 evaluable patients; 71% (110/154) had no further treatment and no disease progression at data cutoff (FDA notice, October 19, 2026). Dostarlimab (Jemperli) received FDA accelerated approval for this indication on October 19, 2026.

When were HARMONi-GI1 and CLARITY-Gastric01 presented?

Both were presented in Presidential Symposium II on October 25: CLARITY-Gastric01 (LBA7, Rui-Hua Xu; invited discussant Salah-Eddin Al-Batran) and HARMONi-GI1 (LBA8, Jian Zhou; invited discussant James J. Harding). Ivonescimab and sonesitatug vedotin are investigational in the US.

Which GI sessions are still ahead at ESMO 2026?

On October 26: a special symposium on upper GI cancer, a pancreatic cancer symposium, and the upper GI rapid oral session with LBA85, 3137RO, LEAP-012 long-term OS (1678RO), 1680RO, OPTIMUM (LBA22) and 473RO. On October 27: congress highlights for lower and upper GI cancers.

Related ESMO 2026 pages

• ESMO 2026 GI slide library
• ESMO 2026 trials: physician posts by trial
• ESMO 2026 conference page: daily highlights and KOL leaderboard
• HERIZON-GEA-01 trial page
• SANO trial page
• RASolute 302 trial page
• AZUR-1 trial page