Disclaimer: This newsletter is for educational and informational purposes only and does not constitute medical, investment, or financial advice, nor does it establish a provider-patient relationship. Content may include forward-looking statements and discussions of investigational therapeutic candidates that are not FDA/EMA approved; their safety and efficacy remain unestablished and clinical outcomes are unpredictable. While we strive for accuracy, all information is provided as is without guarantees. As of the date of publication, the author holds no direct equity positions in the specific companies mentioned in this issue nor receives third-party compensation for this coverage. Please find a complete version of our disclaimers at the bottom of the article and linked here.
Press ⬇️ to go down to a section and ⬆️ to go back up to the Table of Contents
Table of Contents
The European Society for Medical Oncology (ESMO) 2026 Congress takes place from October 23 to October 27, 2026, in Madrid, Spain. At Biotech Readout, we try to go the extra mile. So, we documented every clinical trial that is set to readout at ESMO 2026 (by hand, yikes!). In this article, we put together an “Abstract Olympics” of sorts and a preview for the most anticipated readouts at Europe’s largest cancer conference:
Abstract Olympics
Most Anticipated Readouts
Conclusion ⬇️
Abstract Olympics
China Overtakes US in ADCs, CAR-T, and Early Stage Clinical Trials
We found that China has dramatically overtaken the EU and has almost caught up with the US in terms of the number of oral presentations and posters at ESMO 2026 (282 US, 243 China, 53 EU).
Turning to therapeutic modalities, the US still accounts for the majority of readouts for antibodies (mAbs), small molecules, and radiopharmaceuticals. I was particularly surprised to find one Chinese company called Sinotau developing a radiopharm (PSMA-targeting [177Lu]Lu-XT381), a space that has thus far seen limited development in China. Their radioactive components make them more highly regulated than traditional therapeutics, so it’s unclear whether Sinotau, or any other Chinese radiopharm peers, are allowed to out-license their molecules to US companies. China’s nuclear power capacity has nearly doubled over the past 10 years according to the US Energy Information Administration, so I suppose we shouldn’t be so surprised to see China-based biotech companies making headway in the radiopharmaceutical space. Meanwhile, China has decisively taken the lead in ADC (76 China versus 50 US) and CAR-T readouts (4 China versus 1 US), although the latter category is rather tepid this year.
Moving to clinical trial phase, we find that China edges out the US in readouts for both Phase 1 and Phase 2 trials (111 China versus 101 US in Phase 2; 92 China versus 91 US in Phase 1). It’s possible that this phenomenon is driven by the three-times higher cost per patient in Western Phase 1 clinical trials versus those in China, which was identified by McKinsey in a recent report. There’s also a likely explanation for why the US still holds the majority of Phase 3 readouts. A landmark precedent was set in February 2022 by then Director of the FDA’s Oncology Center of Excellence (OCE), Dr. Richard Pazdur, when the Oncologic Drugs Advisory Committee (ODAC) voted 14:1 against recommending sintilimab for approval because the drug’s Biologics License Application (BLA) relied on a pivotal Phase 3 trial conducted entirely within mainland China. The FDA subsequently issued Eli Lilly and its Chinese partner, Innovent, a complete response letter (CRL). Dr. Pazdur and the FDA established that data generated exclusively in a single foreign country, even if scientifically sound and compliant with local standards, is typically insufficient for US approval if it lacks generalizability to the US population. Since then, all companies seeking FDA approval have unofficially been required to run a Phase 3 Multi-Regional Clinical Trial (MRCT) that includes a Western population, in order to mitigate against the risk of becoming the next sintilimab.
Merck Holds a Commanding Lead
Bolstered by their record-setting immuno-oncology franchise, Keytruda (pembrolizumab), Merck holds the commanding lead among the companies with the most oral presentations and posters at ESMO 2026. Bristol Myers Squibb held the 4th spot with anti-PD1 mAb Opdivo (nivolumab) and anti-CTLA4 mAb Yervoy (ipilimumab), in addition to investigational agents Iza-bren (EGFR x HER3 ADC) and pumitamig (PDL1 x VEGF-A mAb). Nevertheless, AstraZeneca and Pfizer claimed the 2nd and 3rd spot, respectively, with a wellspring of ADCs, multi-specific antibodies, and more selective small molecules, in addition to their own PD-(L)1 franchises.
China-based companies have made impressive progress by building up their own immuno-oncology franchises. Hengrui’s anti-PDL1 mAb adebrelimab stole the show among China-based companies, rising to the 5th most productive company overall. Similarly, Qilu surged ahead with their anti-PD1 mAb iparomlimab and anti-CTLA4 mAb tuvonralimab. As did Junshi with their anti-PD1 mAb toripalimab and BeOne with their anti-PD1 mAb Tevimbra (tislelizumab).
China Claims the Lead in Seven Frontier Targets
We sorted targets into two buckets: “Frontier Targets” or “Mature Targets”. The distinction was based on the number of approved medicines for a given target, its degree of crowdedness, and its level of clinical validation. Generally, “Mature Targets” have many approved drugs and/or are in crowded spaces with a higher level of clinical validation, whereas “Frontier Targets” are less established but more cutting edge. China is ahead of the US for several of these targets, which are highlighted in the graph below. Notably, China-based therapeutics lead in seven of the twenty Frontier Targets indicated here.
Most Anticipated Readouts
Moderna Polarizes Industry Watchers
On October 24, 2026 (Saturday), Merck and Moderna are set to present their landmark Phase 3 results from the INTerpath-001 trial, evaluating the 34-valent personalized mRNA-based neoantigen therapy intismeran autogene (formerly mRNA-4157 / V940) combined with Keytruda (pembrolizumab) versus Keytruda (pembrolizumab) alone in the adjuvant treatment of resected high-risk stage IIB-IV melanoma (highlighted in blue in the table below). We covered their initial announcement in Weekly Readout #19 and its broader impact on the field of precision oncology in a Frontiers in Medicine article here. Needless to say, this data has been polarizing. The biotech community has generally been more skeptical, demanding to see quantitative Phase 3 results (it’s here!). Meanwhile, the results have drawn the attention of the tech/generalist community, who are generally more enthusiastic and claim the victory as their own because they believe the drug was made using artificial intelligence (it wasn’t).
Regardless of that debate, Merck’s and Moderna’s ESMO 2026 presentation will once and for all set the record straight by reporting the INTerpath-001 trial’s primary endpoint of Recurrence-Free Survival (RFS) in melanoma. Barclays analyst Elli Merle was recently quoted by Biotech TV as citing a hazard ratio (HR) of 0.6 as the bogey amongst biotech industry watchers as a litmus test for generalizability outside of melanoma, noting the HR of 0.55 in the smaller Phase 2b KEYNOTE-942. Supposedly, the headline number has leaked with a HR of 0.58 (see the X post below), which narrowly exceeds expectations (0.6), but a company press release will speak to the legitimacy of this report. (Update: ESMO has confirmed the leak and lifted the embargo)
Personally, I believe that a better litmus test for whether intismeran autogene could work in immune “cold” tumor types outside of melanoma is actual clinical data in those tumors, which we have a chance to see at ESMO 2026 (highlighted in pink in the table above). In a poster (Abstract 3151P), Merck and Moderna noted initial signs of T-cell responses from an open-label, phase 1 study (NCT03313778) in adults with resected pancreatic ductal adenocarcinoma (PDAC), a notoriously immune “cold” tumor:
Background
Pancreatic ductal adenocarcinoma (PDAC) is characterized by high recurrence rates after resection and limited benefit from conventional immunotherapies. Intismeran autogene (formerly referred to as mRNA-4157 or V940) is an individualized mRNA-based neoantigen therapy designed to enhance antitumor immunity by targeting patient specific tumor mutations. Here, we report translational analyses from the PDAC cohort of the phase 1 mRNA-4157-P101 study.
Methods
In this open-label, phase 1 study (NCT03313778), adults with resected PDAC sequentially received intismeran monotherapy lead-in, combination with standard-of-care adjuvant FOLFIRINOX, and resumption of intismeran monotherapy (1 mg IM Q3W for up to a total of 16 doses). Primary objectives were safety and feasibility; recurrence-free survival (RFS) was a clinical secondary endpoint; immunogenicity as an exploratory endpoint was assessed by IFN-γ ELISpot and TCR sequencing.
Results
Twenty patients (pts) (stage IA–III) were treated, including 7 who received prior neoadjuvant therapy. Tumors were characterized by low TMB (range 0.26 to 2.75 mutations/Mb) and KRAS mutations were observed in 65% (n = 13) of patients’. The median number of encoded neoantigens per intismeran was 34. Among 19 immunogenicity-evaluable pts, evidence of neoantigen-specific T cell responses were detected in all 19 evaluable pts. Longitudinal TCR sequencing demonstrated expansion of novel T cell clones following intismeran treatment. T cell responses increased over time, with higher responses observed following completion of chemotherapy and continued intismeran dosing. In a subset of pts with apheresis samples (n=10), neoantigen-level analyses identified intismeran-specific neoantigens driving T cell responses. RFS, safety, and relationship with clinical outcomes will be presented.
Conclusions
Adjuvant intismeran with FOLFIRINOX treatment induced neoantigen-specific T cell responses in all immunogenicity-evaluable patients with resected PDAC. Expansion of novel T cell clones supports the ability of intismeran to generate neoantigen-specific immunity in a low-TMB malignancy.
Source: ESMO 2026 Abstract 3151P
PD-1 x VEGF Ventures Outside of Lung Cancer
Speaking of expansion outside of a therapeutics’ primary tumor type, Summit’s China-based partner Akeso is set to report results of their Phase 3 HARMONi-GI1 trial on Sunday, October 25, 2026 (highlighted in blue in the table below). The trial evaluates ivonescimab (AK112/SMT112), the pioneering PD-1 x VEGF bispecific antibody, combined with chemotherapy in the first-line treatment of advanced biliary tract cancer (1L BTC). This represents ivonescimab’s first Phase 3 readout outside of non-small cell lung cancer (NSCLC). Dr. Jian Zhou (Shanghai, China) will present the comprehensive dataset during Presidential Symposium II. Industry watchers expect to see overall survival (OS), progression free survival (PFS), subgroup performance, and safety & tolerability as a crucial precedent for whether dual PD-1 x VEGF inhibition can displace standard checkpoint inhibitors across broader GI tumor types.
Summit/Akeso aren’t alone in the PD-1 x VEGF bispecific space. BioNTech, Pfizer, and AbbVie race to develop bispecific programs of their own. China-based CStone’s program jumped out at me, with their PD-1 x VEGF x CTLA4 trispecific program CS2009, currently being evaluated in mCRC and NSCLC (highlighted in pink in the table below).
RAS Inhibitors Take On Pancreatic & Lung Cancer
Last, but certainly not least, I’m highlighting the RAS inhibitor space. The presentation of the RASolute 302 trial marks a victory lap for Rasonque (daraxonrasib), Revolution Medicines’ oral, RAS(ON) multi-selective inhibitor, in metastatic pancreatic ductal adenocarcinoma (mPDAC) (highlighted in blue in the table below). While initial topline survival wins and the subsequent FDA approval of daraxonrasib have already changed the clinical conversation in mPDAC (we covered it in Weekly Readout #20), the detailed ESMO 2026 presentation could offer more granular insights:
Detailed Subgroup Analyses: Investigators are spotlighting performance across specific RAS G12 variant subtypes (such as G12D, G12V, and G12R) to evaluate if multi-selective inhibition yields uniform depth of response across different genomic iterations.
Durability and Tail of the Curve: Detailed looks at Progression-Free Survival (PFS) and Overall Survival (OS) curves compared head-to-head against investigator’s choice of standard-of-care cytotoxic chemotherapy in previously treated mPDAC.
Of course, RevMed’s success has spurred a gold rush in the RAS inhibitor space. On October 25, 2026 (Sunday), Roche/Genetech will showcase data from their Phase 3 Krascendo 1 trial, which evaluated their KRAS G12C inhibitor divarasib in patients with advanced KRAS G12C-mutant NSCLC in combination with chemo-IO, the current 1L standard of care (SOC) for pts with NSCLC and PD-L1 expression 0-100% (highlighted in pink in the table below). China-based competitor Hengrui is set to discuss 5 abstracts, evaluating their KRAS G12D inhibitor HRS-4642 across PDAC and NSCLC (highlighted in pink in the table below). China-based competitor GenFleet will present on their trimeric complex pan-RAS (ON) inhibitor GFH276, which is closer to daraxonrasib. Erasca will also present on their Wuxi-licensed pan-KRAS inhibitor ERAS-4001, which is intentionally designed to spare HRAS and NRAS isoforms to achieve a wider therapeutic index (theoretically).
Conclusion
Of course, there are lots of readouts that I did not cover in this preview. I will post another article on ESMO 2026 after the conference has finished, which will more broadly cover high-impact datasets. Until then, enjoy ESMO, and subscribe so that you don’t miss our post-conference recap!
Love biotech? Check out Biotech Readout’s full content library, or navigate directly to a segment that interests you:
Frontiers in Medicine: Exploring the frontiers of our understanding and treatments for disease.
Medical History: Recovering forgotten relics in the history of medicine.
Acquisitions: Exploring the innovation behind acquired companies.
Weekly Readout: A digest of new clinical data from the past week.
To contact us, please send us an email at biotechreadout@gmail.com
Disclaimers
Investigational Status Disclaimer
The therapeutic candidates discussed in this newsletter are currently in clinical development and have not been approved for commercial sale by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), or other global regulatory authorities. Their safety and efficacy have not been established. References to pipeline products and ongoing clinical trials involve significant risks and uncertainties. Statements regarding the potential safety, potency, or efficacy of investigational drugs reflect current hypotheses and are not a guarantee of future performance or regulatory clearance. The outcome of clinical trials is inherently unpredictable, and clinical results from earlier stages may not be predictive of results in later, larger-scale trials.
No Medical Advice Disclaimer
This newsletter is for informational and educational purposes only. The content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or another qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read in this publication.
No Patient-Provider Relationship Disclaimer
The information provided in this newsletter is for educational and analytical purposes only. Receipt of this information, or any interaction with this content, does not create a physician-patient, pharmacist-patient, or any other professional-provider relationship between you and the authors or publishers. This newsletter should not be used as a substitute for a personal consultation with a qualified healthcare professional.
Forward-Looking Statements Disclaimer
This newsletter contains “forward-looking statements” regarding future events, including clinical trial timing, regulatory milestones, and projected market performance. These statements are based on current expectations and assumptions that are subject to significant risks and uncertainties. Actual results may differ materially from those expressed or implied. We undertake no obligation to update these statements as a result of new information or future developments.
Third-Party Links & Content Disclaimer
This newsletter contains links to third-party websites, including clinical trial registries and corporate presentations. Biotech Readout does not endorse, guarantee, or assume responsibility for the accuracy or reliability of any information offered by third-party providers.
Errors and Omissions Disclaimer
While we strive for technical accuracy, the information in this newsletter is provided on an “as is” basis with no guarantees of completeness, accuracy, or timeliness. Biotech Readout assumes no liability for any errors or omissions in the content of this publication.
Non-Endorsement Disclaimer
Any reference to specific commercial products, processes, or services by trade name, trademark, or manufacturer does not constitute or imply an endorsement or recommendation by the author. All trademarks are the property of their respective owners.
No Investment Advice Disclaimer
This newsletter is for informational purposes only and does not constitute financial, investment, or legal advice. The author is not a registered investment advisor. You should consult with a professional financial advisor before making any investment decisions. The biotechnology sector is highly volatile; past performance is not indicative of future results.
Conflict of Interest Disclaimer
The author of this newsletter maintains a position of independence. At the time of publication, the author holds no direct financial interest, equity, or options in any of the companies mentioned in this report. No compensation has been received from any third party to feature or analyze specific therapeutic candidates or corporate entities.





