On May 21, 2026 Flatiron Health reported its presence at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting happening from May 29 – June 2, 2026, in Chicago, Illinois. Flatiron’s high-quality real-world data and innovative research capabilities are featured across 25+ research acceptances, including 14 Flatiron-authored poster presentations and online publications.

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Flatiron’s presence at ASCO (Free ASCO Whitepaper) 2026 closely follows the launch of Flatiron Telescope, a multi-agent adaptive analytics platform designed to help life sciences teams find the right patients faster, assess study feasibility in real time, and generate oncology insights on demand. Flatiron Telescope will be demonstrated at the company’s booth (#21149) for attendees to build and iterate on patient cohorts using natural language and generate insights in real time.

"Our presence at ASCO (Free ASCO Whitepaper) 2026 proves that innovation and rigor aren’t at odds—they reinforce each other," said Emily Castellanos, MD, MPH, Senior Medical Director and Head of Research Oncology at Flatiron Health. "From digital twins that simulate patient outcomes to LLM-enabled treatment pattern analysis, our work demonstrates that Flatiron is defining—not just participating in—the evolution of oncology evidence. These 25+ acceptances showcase our unified, global oncology engine and reinforce our position as the gold standard in oncology intelligence, trusted to guide the highest-stakes decisions across the industry."

Research highlights include:

Digital twin modeling for treatment prediction: validating novel counterfactual prediction approaches in NSCLC using clinical trial data, demonstrating how AI-enabled simulation can move beyond observational analysis to model patient outcomes under different treatment scenarios
Physician adoption of landmark clinical trial findings: a large-language model-based analysis documenting how ASCO (Free ASCO Whitepaper) plenaries translate to clinical decision-making in real-world practice, the largest such analysis of clinician-patient trial discussions to date
Recurrence risk prediction in early breast cancer: leveraging multi-site observational data to build predictive models for early breast cancer populations, showing how scale enables discovery in underrepresented patient groups
Post-operative circulating tumor DNA as a prognostic indicator: examining ctDNA’s role in identifying high-recurrence risk in muscle-invasive and locally advanced bladder cancer, demonstrating the value of real-world biomarker data in routine practice
Real-world treatment patterns in platinum-resistant ovarian cancer: analyzing platinum re-challenge outcomes in a population with limited evidence guidance, highlighting how Flatiron’s depth of longitudinal data reveals clinical practices that diverge from trial design and guidelines
Join Flatiron Health at booth #21149 for a demo of Flatiron Telescope and follow Flatiron Health on X and LinkedIn for more updates from #ASCO26.

Poster Presentations
From plenary to practice: a large language model (LLM)-based thematic analysis of landmark clinical trial discussions and factors influencing their real-world adoption
Aaron B Cohen, Tori Williams, Charu Aggarwal, Angela M DeMichele, Ritvik Vasudevan, Niquelle Brown Wadé, Shreya Balakrishna Rosseau, Erin Fidyk, Blythe Adamson
Author affiliations: Penn Medicine, Flatiron Health
Abstract Number: 1583
Poster Session: Care Delivery/Models of Care
Poster Board: 501
Date and Time: May 30, 2026, 9-12 PM

External validation of a deep learning CT biomarker to predict first-line immune checkpoint inhibitor monotherapy-associated survival in PD-L1-high metastatic non-small cell lung cancer
Ravi B. Parikh, Jacqueline Law, Lauren M. Damato, Paul M. Novotny, Joel Brooks, Ryan Beasley, Chiharu Sako, Petr Jordan, George R. Simon
Author affiliations: Emory University, Onc.AI, OhioHealth, Flatiron Health
Abstract Number: 2534
Poster Session: Developmental Therapeutics—Immunotherapy
Poster Board: 324
Date and Time: May 30, 2026, 1:30- 4:30 PM

Prognostic value of post-operative circulating tumor DNA (ctDNA) in real-world treatment and outcomes among patients (pts) with muscle invasive (MIBC) and locally advanced (LA) bladder cancer (BC)
Khilna Patel, Danni Zhao, Erin Fidyk, Eunice A. Hankinson, Aashay Mahesh Mehta, Matthew Pesavento, Arun Sujenthiran
Abstract Number: 4600
Poster Session: Genitourinary Cancer—Kidney and Bladder
Poster Board: 79
Date and Time: May 31, 2026, 9-12 PM

Real-world second-line treatment patterns and outcomes by platinum sensitivity in extensive-stage small cell lung cancer in the post-immunotherapy era
Catherine Rinaldi, Samantha Reiss, Jenna Collins, Karen Schwed, Michael Chiu, Emily Castellanos
Abstract Number: 8083
Poster Session: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Poster Board: 557
Date and Time: May 31, 2026, 9-12 PM

Comparison of real-world overall survival between atezolizumab- and durvalumab-containing first-line induction and maintenance regimens in extensive-stage small cell lung cancer
Apar Kishor Ganti, Jeremy Snider, Jessie T. Yan, Catherine Rinaldi, Amy Nguyen, Badri Rengarajan, Deb Profant, Douglas S. Fuller, Ellen Hu, Trong Kim Le, Navit Naveh, Xiaozhou Fan
Author affiliations: Jazz Pharmaceuticals, Nebraska Western Iowa Health Care System/University of Nebraska Medical Center, Flatiron Health
Abstract Number: 8093
Poster Session: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Poster Board: 567
Date and Time: May 31, 2026, 9-12 PM

A risk stratification schema for patients with non-small cell lung cancer with multiple organ metastases
Gabriela Esnaola, Mengru Wang, Benjamin Resio, Alexander Pan, Daniel Lee, Aaron B. Cohen, Maneet Kaur, Madeleine Schmitter, Jeffrey J. Ishizuka, Kelly Olino
Author affiliations: Yale School of Medicine, Dana-Farber Cancer Institute, Flatiron Health
Abstract Number: 11138
Poster Session: Quality Care/Health Services Research Track
Poster Board: 121
Date and time: June 1, 2026, 9-12pm

Platinum re-challenge in platinum-resistant ovarian cancer: real-world patterns and outcomes
Prakirthi Yerram, Matt Bye, Khilna Patel, Nicole Nasrallah, Michael Curry, Emily Castellanos
Abstract Number: 5566
Poster Session: Gynecologic Cancer
Poster Board: 232
Date and Time: June 1, 2026, 9-12pm

Using ML to predict rapid progression for patients (pts) with HR+/HER2- metastatic breast cancer (mBC) treated with frontline (1L) CDK 4/6 inhibitors (CDK 4/6i)
Michael Peng, Gabriel Rios, Melissa Estevez, Jamie Colasurdo, Mohammad Forouzanfar, Kelly Hoang, Meng Wang
Author affiliations: Gilead Sciences, IQVIA, Flatiron Health
Abstract Number: 1025
Poster Session: Breast Cancer—Metastatic
Poster Board: 139
Date and Time: June 1, 2026, 1:30-4:30 PM

RW post-progression outcomes following first-line (1L) ribociclib (RIB) + aromatase inhibitor (AI) versus AI alone in African American and low socio-economic status (SES) patients with HR+/HER2− metastatic breast cancer (MBC) in US.
Vk Gadi, Lowell L. Hart, Paolo Tarantino, Priyanka Sharma, Sarah L. Sammons, Panagiotis Mayros, Maneet Kaur, Nada Boualam, Catherine Keane, Gary M. Sopher, Purnima Pathak, Hope S. Rugo
Author affiliations: University of Illinois Cancer Center, Wake Forest University/Florida Cancer Specialists, Harvard Medical School, University of Kansas Medical Center, Dana-Farber Cancer Institute, Novartis, City of Hope Comprehensive Cancer Center, Flatiron Health
Abstract Number: 1073
Poster Session: Breast Cancer—Metastatic
Poster Board: 187
Date and Time: June 1, 2026, 1:30-4:30 PM

Recurrence risk prediction using a large, multi-site observational dataset of patients with early breast cancer including early-onset disease
Lilia Bouzit, Gabriel Rios, Smriti Karwa, Erin Fidyk, Catherine Keane, Melissa Estevez
Abstract Number: 547
Poster Session: Cancer—Local/Regional/Adjuvant
Poster Board: 32
Date and Time: June 1, 2026, 1:30-4:30 PM

Online Acceptances
Digital twin models for counterfactual prediction in NSCLC: a validation study using clinical trial data
Aaron B Cohen, Sandra Giffith, Melissa Estevez, Brandon Arnieri, Matt H Secrest, Joe Manfredonia, Marcello Ricottone, Richard Knoche, Jacqueline Law, Melina Marmarelis
Author affiliations: Genentech, University of Pennsylvania, Flatiron Health
Abstract Number for Publication: e20517

Real-world treatment patterns and outcomes among patients with high-risk and very high-risk non-metastatic prostate cancer
Eunice A. Hankinson,Yunzhi Qian, Patrick Ward, Khilna Patel, Aaron Dolor, Arun Sujenthiran
Abstract Number for Publication: e17120

Drivers of organotropism and patterns of metastatic progression in metastatic non-small cell lung cancer
Gabriela Esnaola, Benjamin Resio, Alexander Pan, Daniel Lee, Aaron B. Cohen, Mengru Wang, Madeleine Schmitter, Jeffrey J. Ishizuka, Kelly Olin
Author affiliations: Yale School of Medicine, Dana-Farber Cancer Institute, Flatiron Health
Abstract Number for Publication: e20541

Real-world biomarker testing rates, targeted therapy use, and clinical outcomes in patients with advanced gastric or GEJ cancer in the United States
Lauren Damato, Noelle S. Liao, Jonathan Bryan, Eunice A. Hankinson, Emily Castellanos
Abstract Number for Publication: e16039

(Press release, Flatiron Health, MAY 21, 2026, View Source [SID1234665970])

On May 21, 2026 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel cancer therapies, reported that it will host an investor webcast featuring members of management on June 3, 2026 at 8:30 am ET to review updated data from CRDF-004, a randomized dose-finding Phase 2 clinical trial evaluating onvansertib in combination with standard-of-care regimens (FOLFIRI/bevacizumab or FOLFOX/bevacizumab) in patients with first-line RAS-mutated metastatic colorectal cancer (mCRC).

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The updated CRDF-004 data will first be presented during a rapid oral session at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 2, 2026 at 8:00 am CT/9:00 am ET and will build on the CRDF-004 data previously presented in January 2026. More details about the oral presentation are available on the Company’s website here and the full abstract is now available on the ASCO (Free ASCO Whitepaper) website.

Investor Webcast Details
The investor webcast will take place on June 3 at 8:30 am ET. To register for and access the live webcast, please visit the "Events" page of the Cardiff Oncology website.

About Onvansertib
Onvansertib is a highly specific, oral PLK1 inhibitor advancing toward a registrational trial in first-line RAS-mutated metastatic colorectal cancer (mCRC). In a randomized Phase 2 trial, onvansertib in combination with FOLFIRI/bevacizumab (first-line standard-of-care) demonstrated dose-dependent improvements in overall response rate and progression-free survival compared to standard-of-care alone, building on findings from a prior Phase 2 trial in second-line RAS-mutated mCRC. Based on these results, the Company has selected the 30 mg dose of onvansertib in combination with FOLFIRI/bevacizumab for advancement into a registrational trial in first-line patients with RAS-mutated mCRC.

Onvansertib is also being evaluated in multiple other cancers through investigator-initiated studies, including metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC), triple-negative breast cancer (TNBC), and chronic myelomonocytic leukemia (CMML).

(Press release, Cardiff Oncology, MAY 21, 2026, View Source [SID1234665986])

On May 21, 2026 Corbus Pharmaceuticals Holdings, Inc. (Nasdaq: CRBP), a clinical-stage company focused on developing promising new therapies in oncology and obesity, reported that the Company’s management team will host a conference call and webcast on Tuesday, May 26 at 8:00 a.m. EDT to discuss updated data for its Phase 1/2 study of CRB-701, a next-generation Nectin-4 antibody drug candidate (ADC), in both head and neck squamous cell carcinoma (HNSCC) as well as cervical cancer. The data, which will be presented at the upcoming 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, represent an April 1, 2026 data cut, and will include clinical response durability data as well as HNSCC patient subgroup analysis.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Corbus also announced today the appointment of former Evercore Managing Director Nishant Saxena as the Company’s first Chief Business Officer, as it advances toward two key anticipated pipeline milestones this summer: the initiation of a registrational study of CRB-701 in second-line HNSCC and the completion of the CANYON-1 Phase 1b dose-ranging, 16-week study (n=240) for CRB-913, a highly peripherally restricted oral CB1 inverse agonist.

"Nishant is an accomplished industry executive with deep expertise across mergers and acquisitions, licensing, partnerships, and capital markets," said Yuval Cohen, Ph.D., CEO of Corbus. "His proven track record of unlocking and delivering value coincides with our transition from an early clinical-stage company to one entering registrational-stage clinical development. We are excited and grateful that he has chosen to join the Corbus team."

Mr. Saxena commented, "The emerging clinical data for CRB-701 in oncology and CRB-913 in obesity are very encouraging, and the Corbus team has done an incredible job advancing these two assets toward important milestones this year," said Mr. Saxena. "I am excited by the clinical and commercial potential for both of these assets, and I look forward to working with Yuval and the rest of the leadership team to advance this portfolio toward its full value and impact."

Nishant Saxena Biographical Details

Mr. Saxena has over 20 years of experience in finance, strategy, capital markets, mergers and acquisitions, and corporate development. Most recently, he was Chief Financial Officer at Jeune Aesthetics, Inc., a wholly owned subsidiary of Krystal Biotech, Inc. (NASDAQ: KRYS). Previously, Mr. Saxena spent over 15 years at Evercore, most recently as a Managing Director in the healthcare group, where he advised on transactions totaling over $500 billion in aggregate value. Mr. Saxena led numerous client engagements and advised on mergers and acquisitions, private placements, initial public offerings, follow-on offerings, partnerships, and structured financing. Earlier in his career, Mr. Saxena held positions of increasing responsibility in private equity, venture capital, and investment advisory firms. Mr. Saxena received a B.S. in Economics and an MBA from the Wharton School at the University of Pennsylvania.

Pre-2026 ASCO (Free ASCO Whitepaper) Conference Call & Webcast Registration Details

Date: Tuesday, May 26, 2026
Time: 8:00 a.m. EDT
Investors Dial 1-877-704-4453
Int’l Investors Dial 1-201-389-0920
Conference ID 13760531
Webcast: Click here
CallMe: Click here

A replay will be available on the Corbus website.

CRB-701 2026 ASCO (Free ASCO Whitepaper) Data Presentation Details

The oral presentation titled, "A phase 1/2 study of the next-generation Nectin-4-targeting antibody–drug conjugate CRB-701 (SYS6002) in patients with recurrent or metastatic cervical cancer," will be presented by Professor Yohann Loriot, Gustave Roussy (Paris) on Friday, May 29 at 4:57 p.m. CDT (Abstract #5508).

The poster presentation titled, "A phase 1/2 study of the next-generation Nectin-4-targeting antibody–drug conjugate CRB-701 (SYS6002) in patients with recurrent or metastatic head and neck squamous cell carcinoma," will be presented by Charlene Mantia, M.D., Dana-Farber Cancer Institute (Boston) on Saturday, May 30 at 4:30 p.m. CDT (Abstract #6062/Poster #519).

2026 ASCO (Free ASCO Whitepaper) HNSCC KOL Event Details

Corbus will host an in-person and virtual KOL event during the 2026 ASCO (Free ASCO Whitepaper) to discuss the updated data from the Phase 1/2 clinical study of CRB-701 in 75 participants with HNSCC.

Date: Monday, June 1, 2026
Time: 6:30 a.m. CDT
Location: Marriott Marquis Chicago
Participants: Corbus Management Team, joined by leading HNSCC Experts:
Ari Rosenberg, M.D., University of Chicago
Glenn Hanna, M.D., Dana-Farber Cancer Institute
Cesar Augusto Perez Batista, M.D., Sarah Cannon Research Institute

A live question-and-answer session will follow the formal presentation. To register for the KOL event, click here. A replay of the event will also be available on the Corbus website.

(Press release, Corbus Pharmaceuticals, MAY 21, 2026, View Source [SID1234665923])

On May 21, 2026 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical oncology innovator advancing late-stage development of investigational first-in-class WEE1 inhibitor azenosertib as a biomarker-driven treatment approach for ovarian cancer, reported that data from Part 1 of the Phase 1b MUIR trial will be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held May 29 – June 2, 2026, in Chicago, Illinois. The poster, titled "Azenosertib Plus Paclitaxel for Platinum-Resistant Ovarian Cancer: Results From a Phase 1b Study," will be presented in the Gynecologic Cancer Poster Session (Abstract #5529, Poster Board #195) on June 1, 2026, from 9:00am–12:00pm CDT.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"Paclitaxel is one of the most widely used chemotherapy agents across tumor types, including in ovarian cancer, and these Phase 1b data show encouraging clinical activity and tolerability of adding azenosertib to paclitaxel in an all-comer platinum-resistant ovarian cancer (PROC) setting," said Ingmar Bruns, M.D., Chief Medical Officer of Zentalis Pharmaceuticals. "Establishing the safety, combinability, and efficacy signal of azenosertib with paclitaxel is an important proof of concept — one that we believe speaks to the broad potential of azenosertib across multiple lines of ovarian cancer and other tumor types where taxanes are commonly used. With our core strategic focus on advancing azenosertib in registration-intended trials as a monotherapy in the Cyclin E1-positive PROC population, the MUIR trial represents an important and complementary part of our broader indication expansion strategy."

"In a heavily pre-treated, all-comer patient PROC population where all patients had received prior paclitaxel, we observed meaningful tumor reductions and durable responses with this azenosertib paclitaxel combination, with an overall response rate of 39% and a median PFS of 7.3 months" said Joyce F. Liu, M.D., MPH, Associate Professor at Dana-Farber Cancer Institute and a study investigator. "At the 250 mg 5:2 intermittent dose — the dose thought to offer the optimal therapeutic index — half of patients achieved a response with a median duration of response of 9.2 months. Interestingly, the clinical activity appears similar in both Cyclin E1-positive and Cyclin E1-negative tumors, suggesting that Cyclin E1 status may not be as important in the azenosertib combination setting where the combination agent is inducing replication stress. These results support continued evaluation of azenosertib-taxane combinations in broader ovarian cancer settings and other tumor types where taxanes are part of the standard of care."

MUIR is a multi-part, open-label Phase 1b clinical trial evaluating azenosertib in combination with chemotherapy in patients with ovarian cancer. Part 1 evaluated azenosertib in combination with four chemotherapy regimens in patients with PROC, with data from the paclitaxel arm presented at ASCO (Free ASCO Whitepaper) as paclitaxel is commonly used across multiple tumor types, including ovarian cancer. Data from the other combination arms will be presented separately at a later date. The findings reflect a December 1, 2025 data cutoff and include 46 patients who received azenosertib across four dose cohorts — 200 mg QD continuously or 200 mg, 250 mg, or 300 mg QD intermittently (5 days on, 2 days off) — in combination with paclitaxel 80 mg/m². All patients had received prior paclitaxel.

Encouraging Activity in All-Comer PROC Population with Activity Across 4 Dose Groups (n=46)
•Overall Response Rate (ORR): 39.1% (95% CI: 25.1–54.6)
•Clinical Benefit Rate (CBR): 58.7% (95% CI: 42.2–73.0)
•Median Duration of Response (DOR): 5.6 months (95% CI: 5.6–9.2)
•Median Progression-Free Survival (PFS): 7.3 months (95% CI: 3.7–7.5)
These results are encouraging in the context of the historical efficacy of paclitaxel monotherapy in PROC, with an ORR of approximately 30% and a median PFS of approximately 4 months.
Clinical activity was broadly comparable in Cyclin E1-positive patients (ORR: 41.4% [95% CI: 23.5-61.1]; median PFS: 7.3 months [95% CI: 3.7-9.1]) and Cyclin E1-negative patients (ORR: 35.7% [95% CI: 12.8-64.9]; median PFS: 5.4 months [95% CI: 1.7-NE]), suggesting that Cyclin E1-positive biomarker status may not be required to derive benefit when azenosertib is combined with a cytotoxic agent.
At the 250 mg intermittent (5:2) dose cohort (n=12), which demonstrated the potential optimal therapeutic index:
•ORR: 50.0% (95% CI: 21.1–78.9), including one complete response
•CBR: 66.7% (95% CI: 34.9-90.1)
•Median DOR: 9.2 months (95% CI: 3.8–NE)
•Median PFS: 5.5 months (95% CI: 1.7–12.9)

Manageable Safety Profile with Low Rate of High-Grade Events Across 4 Dose Cohorts (n=46)
•Most common all-grade treatment-related adverse events (TRAEs): fatigue (60.9%), anemia (58.7%), nausea (52.2%), and neutropenia (50.0%).
•Most frequent Grade ≥3 TRAEs: neutropenia (30.4%) and anemia (19.6%); rates of high-grade fatigue and nausea were less than 10%.
•Serious TRAEs occurred in approximately 20% of patients; the most frequent were fatigue, diarrhea, and neutropenia, each occurred in 2 patients.
•Of 15 patients (32.6%) who discontinued due to adverse events, approximately half discontinued paclitaxel only and were able to continue on azenosertib monotherapy until disease progression
•One G5 event due to sepsis was assessed as related to azenosertib by the investigator (previously reported in June 2024). While the role of azenosertib cannot be excluded, the event may have been attributable to the patient’s advanced disease, given the absence of neutropenia and negative blood cultures at the time of the event.
The poster will be available at View Source after ASCO (Free ASCO Whitepaper).
About MUIR Clinical Trial
MUIR (ZN-c3-002) is a multi-part, open-label Phase 1b clinical trial (NCT04516447) evaluating the safety, efficacy, and preliminary clinical activity of azenosertib in combination in patients with ovarian cancer.

Part 1 enrolled patients with platinum-resistant ovarian cancer (PROC) treated with azenosertib in combination with one of four chemotherapy regimens: carboplatin, gemcitabine, pegylated liposomal doxorubicin, or paclitaxel. Primary objectives are safety and tolerability, with key secondary objectives including clinical activity assessed by objective response rate, duration of response, and progression-free survival per RECIST v1.1.

Part 2 is evaluating azenosertib plus bevacizumab as maintenance regimen (first [1L] or second line [2L]) in patients with advanced ovarian, peritoneal, or fallopian tube cancer following platinum-based chemotherapy. The dose expansion portion will evaluate azenosertib at the recommended dose in combination with bevacizumab in patients with platinum-sensitive ovarian cancer in 2L who progressed while on a PARP inhibitor for 1L maintenance. The primary objective is safety and tolerability; secondary objectives include preliminary clinical activity of the combination as assessed by progression-free survival for the dose expansion portion.

About Azenosertib
Azenosertib is an investigational, potentially first-in-class, selective, and orally bioavailable inhibitor of WEE1 currently being evaluated in clinical studies in ovarian cancer and additional tumor types. WEE1 acts as a master regulator of the G1-S and G2-M cell cycle checkpoints, through negative regulation of both CDK1 and CDK2, to prevent replication of cells with damaged DNA. By inhibiting WEE1, azenosertib enables cell cycle progression, despite high levels of DNA damage, thereby resulting in the accumulation of DNA damage and leading to mitotic catastrophe and cancer cell death.

Azenosertib is in late-stage development as a potential treatment for Cyclin E1-positive platinum-resistant ovarian cancer (PROC). There is currently no approved treatment option specifically for this biomarker-selected population which comprises approximately 50% of PROC patients. Cyclin E1 protein overexpression has been established as a sensitive and specific predictive biomarker for identifying patients who could potentially derive benefit from azenosertib treatment, based on retrospective analysis of azenosertib studies in PROC. Validation of the Cyclin E1 companion diagnostic assay is ongoing in the DENALI and ASPENOVA trials.

Azenosertib has been granted Fast Track Designation by the U.S. FDA for the treatment of patients with Cyclin E1-positive platinum-resistant ovarian cancer. Fast Track Designation is intended to facilitate the development and expedite the review of therapies that have the potential to treat serious conditions and address unmet medical needs.

(Press release, Zentalis Pharmaceuticals, MAY 21, 2026, View Source [SID1234665939])

On May 21, 2026 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported updated data from the Phase 1 PoC clinical study of its first-in-class PD-1/IL-2α-bias bispecific fusion protein IBI363 (Takeda R&D code: TAK-928) in the treatment of advanced immunotherapy(IO)-resistant non-small cell lung cancer (NSCLC) at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. An overview of the abstract information is provided below, and the full abstract is available here. More detailed results will be presented during the conference.

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Updated data from this PoC study conducted in China, showed that after extended follow-up, IBI363 continued to demonstrate a manageable long-term safety profile in IO-resistant NSCLC. Notably, the long-term follow-up data showed strong overall survival (OS) in both squamous NSCLC and adenoNSCLC, supporting the durable benefits driven by IBI363’s unique dual mechanism of immune checkpoint blockade plus cytokine agonism.

Based on the data from this study, IBI363 has entered a global Phase 3 clinical study (MarsLight-11) for IO-resistant squamous NSCLC, the clinical trial design of which will also be presented at this ASCO (Free ASCO Whitepaper). Pending regulatory communications, initiation of a global Phase 3 clinical study of IBI363 for IO-resistant non-squamous NSCLC is also planned.

Updated PoC Clinical Data of IBI363 in Immunotherapy-Resistant Advanced NSCLC

The abstract at this conference reported updated data on IBI363 monotherapy in subjects with advanced NSCLC (ClinicalTrials.gov, NCT05460767). As of the follow-up cutoff date of November 20, 2025, a total of 136 subjects with NSCLC had received IBI363 monotherapy (2 μg/kg QW~4mg/kg Q3W).

IBI363 Showed Robust Survival Benefits with a Long Tail Effect in IO-Resistant Squamous NSCLC

All 67 squamous NSCLC patients had no known EGFR mutations. Among them, 28 patients received IBI363 at 1 mg/kg Q2W or 1.5 mg/kg Q3W, and 31 patients received IBI363 at 3 mg/kg Q3W. In the 3 mg/kg Q3W dose group, the median PFS reached 10.1 (95%CI 6.0, 14.0) months, and the median OS achieved 18.2 (95%CI 10.7, NE; maturity 48.4%) months, with a 24-month OS rate of 47.8% (95%CI 28.7, 64.7).
Previously, in the TROPION–Lung01 study that also enrolled NSCLC patients previously treated with immunotherapy, the docetaxel (standard of care) control group achieved a median overall survival (OS) of 9.4 months and a 24–month OS rate of 14.8% in patients with squamous NSCLC. The long–term follow–up data of IBI363 demonstrate a highly competitive survival advantage.
IBI363 Showed Potential for Long-Term Survival Benefits with a Long Tail Effect in IO-Resistant Wild-type AdenoNSCLC, Especially in Patients with a Smoking History

Among the 58 patients with EGFR wild-type adenoNSCLC, 30 patients received IBI363 at 0.6 mg/kg Q2W or 1 mg/kg Q2W or 1.5 mg/kg Q3W, and 25 patients received IBI363 at 3 mg/kg Q3W. In the 3 mg/kg dose group, the median PFS reached 4.2 (95%CI 3.0, 7.0) months, and the median OS achieved 15.2 months (95%CI 9.6, NE; maturity 56.0%), with a 24-month OS rate of 42.7% (95%CI 23.1, 61.0).
Smoking history may be an important influencing factor for the efficacy in immuno-resistant adenoNSCLC. In adenoNSCLC subjects with a smoking history, better survival benefits were observed. The median OS for smokers across all dose groups (n=31) reached 23.4 (95%CI 11.3, NE, maturity 48.4%) months.
Previously, in the TROPION–Lung01 study that also enrolled NSCLC patients previously treated with immunotherapy, the docetaxel (standard of care) control group achieved a median overall survival (OS) of 12.3 months and a 24–month OS rate of 21.7% in patients with non-squamous NSCLC. The long–term follow–up data of IBI363 demonstrate a highly competitive survival advantage.
IBI363 Showed a Favorable Safety Profile in Long-Term Follow-up

In the long-term follow-up of the overall population (n = 136), IBI363 demonstrated a favorable safety profile: treatment-emergent adverse events (TEAEs) of grade 3 or above were present in 48.5% of patients. The most common adverse events were mainly arthralgia (52.2%, ≥grade 3 3.7%), anemia (46.3%, ≥grade 3 4.4%), and rash (39.0%, ≥grade 3 8.8%), which were mostly controllable and manageable with mild-to-moderate AEs. No new safety signals were observed.
Dr. Hui Zhou, Chief R&D Officer (Oncology Pipeline) of Innovent, stated: "Lung cancer remains the most common malignant tumor worldwide. Although immunotherapy has transformed the treatment landscape of NSCLC, therapeutic options are still very limited for patients without driver gene mutations who have failed immunotherapy, with overall survival typically less than 12 months. With longer follow-up, we are encouraged to see outstanding survival outcomes with IBI363 in IO-resistant NSCLC across both squamous and adenoNSCLC. These results further underscore the novel mechanism of IBI363 and its ‘tailing effect’ driven by dual immune checkpoint blockade and cytokine agonism. We hope it will offer a new treatment option for this large patient population and ultimately deliver long-term survival benefits."

About IBI363 (PD-1/IL-2α-bias Bispecific Fusion Protein)

IBI363 is a first-in-class PD-1/IL-2α-bias bispecific fusion protein developed by Innovent Biologics. It functions by both blocking the PD-1/PD-L1 pathway and selectively activating the IL-2 pathway. The IL-2 arm of IBI363 is designed to maintain its affinity for IL-2Rα while reducing binding to IL-2Rβ and IL-2Rγ, thereby minimizing toxicity. The PD-1 binding arm blocks PD-1 and selectively delivers IL-2 to the tumor.

IBI363 is being evaluated in a series of clinical trials globally, led by a pivotal Phase II study in China in previously untreated acral and mucosal melanoma and a global multi-regional Phase III trial in immunotherapy-resistant squamous NSCLC. In parallel, multiple Phase Ib/II trials are evaluating IBI363 in NSCLC and CRC including the first-line and later line settings, and in additional tumor types. IBI363 has received two Fast Track Designations (FTD) from the U.S. FDA and three Breakthrough Therapy Designations (BTD) from China NMPA so far.

In October 2025, Innovent entered into a license and collaboration agreement with Takeda, under which Innovent and Takeda will co-develop IBI363 (Takeda R&D code: TAK-928) globally and co-commercialize IBI363 in the U.S., and Takeda will exclusively commercialize IBI363 worldwide other than the U.S. and greater China.

(Press release, Innovent Biologics, MAY 21, 2026, View Source [SID1234665955])