On May 21, 2026 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported pivotal data for neladalkib, an investigational ALK-selective inhibitor, in TKI pre-treated patients with advanced ALK-positive non-small cell lung cancer (NSCLC) from the global, single-arm ALKOVE-1 Phase 1/2 clinical trial, and preliminary data in patients with advanced ROS1-positive solid tumors other than NSCLC from the global, single-arm ARROS-1 Phase 1/2 clinical trial of zidesamtinib, an investigational ROS1-selective inhibitor, to be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from May 29 – June 2, 2026, in Chicago.

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"The pivotal data for neladalkib in TKI pre-treated patients with advanced ALK-positive NSCLC enabled our recent NDA submission to the FDA, and represent important progress toward our goal of offering a new treatment option for this patient population," said Christopher Turner, M.D., Chief Medical Officer of Nuvalent. "Collectively, these data as well as preliminary data from the TKI-naïve cohort of our ALKOVE-1 study are supportive of further investigation of neladalkib in the global Phase 3 ALKAZAR trial of neladalkib compared to alectinib for TKI-naïve ALK-positive NSCLC, a critical step towards our ultimate goal of moving neladalkib up the treatment paradigm. We look forward to sharing these data with the medical community during an oral presentation at ASCO (Free ASCO Whitepaper), and are deeply grateful to the patients, caregivers, and investigators who have made this milestone possible."

"These data build on the consistent characterization of neladalkib across preclinical and Phase 1 investigations," said Jessica J. Lin, M.D., Program Director of Thoracic Medical Oncology at the Mass General Brigham Cancer Institute, Associate Professor of Medicine at Harvard Medical School, and presenting author. "The data support neladalkib’s potential to deliver on its design goals as an option for patients with ALK-positive NSCLC, including those whose disease progresses with brain metastases or resistance mutations, or who are unable to tolerate the currently available TKIs."

"We also continue to progress the development of zidesamtinib, our ROS1-selective inhibitor, and are pleased to share the preliminary activity observed in patients with ROS1-positive cancers other than NSCLC," said Darlene Noci, A.L.M., Chief Development Officer of Nuvalent. "These data highlight zidesamtinib’s potential for patients with ROS1-positive solid tumors outside of NSCLC, and we believe reinforce the importance of widespread genomic testing. We continue to enroll adult and adolescent TKI-naïve and TKI pre-treated patients with advanced ROS1-positive solid tumors outside of NSCLC in the global Phase 2 portion of our ARROS-1 study, and look forward to providing additional updates in the future."

Pivotal Data for Neladalkib in TKI Pre-treated Patients with Advanced ALK-positive NSCLC from ALKOVE-1 Clinical Trial

Title: ALKOVE-1: Efficacy and safety of neladalkib in patients with advanced ALK+ NSCLC
Presenting Author: Jessica J. Lin, M.D.1
Abstract Number: 8503
Oral Session Title: Lung Cancer—Non-Small Cell Metastatic
Presentation Date and Time: May 29, 2026, 1:00 PM-4:00 PM CDT
Location: Hall D2

The pivotal data to be presented, initially announced in November 2025, are from TKI pre-treated patients with advanced ALK-positive NSCLC treated with neladalkib in the global, registration-directed ALKOVE-1 Phase 1/2 clinical trial. In this population, neladalkib demonstrated encouraging overall activity, including intracranial responses, the ability to address key drivers of disease progression, and a generally well-tolerated safety profile consistent with its ALK-selective, TRK-sparing design. These data served as the foundation for the company’s New Drug Application (NDA) submission, announced in April 2026, to the U.S. Food and Drug Administration (FDA) for neladalkib in TKI pre-treated advanced ALK-positive NSCLC.

Preliminary Data for Zidesamtinib in Patients with Advanced ROS1-positive Solid Tumors Other than NSCLC from ARROS-1 Clinical Trial

Title: Zidesamtinib efficacy and safety in patients with advanced ROS1-positive solid tumors other than NSCLC in the ARROS-1 study
Presenting Author: Benjamin Solomon, M.D., Ph.D.2
Abstract Number: 3108
Poster Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Session Date and Time: May 30, 2026, 1:30 PM-4:30 PM CDT
Location: Hall A
Poster Board Number: 245

Preliminary data are reported for 15 response-evaluable patients enrolled across 10 solid tumor types outside of NSCLC in the Phase 1 and Phase 2 portions of the ARROS-1 clinical trial as of a data cutoff date of September 22, 2025. The majority (12/15) of patients received the recommended Phase 2 dose of 100 mg once daily. Patients were refractory to standard-of-care therapies (60%, 9/15) or were previously treated with a ROS1 TKI (40%, 6/15), and 73% (11/15) of patients had received prior chemotherapy.

Among all patients with advanced ROS1-positive solid tumors treated with zidesamtinib, an objective response rate of 40% (6/15) was observed, with responses seen for ROS1 TKI-naïve patients refractory to standard-of-care therapies, and for those who had received a prior ROS1 TKI. As of the data cutoff date, four of the six responders remained on treatment with zidesamtinib. Three case studies support zidesamtinib’s potential in a range of treatment settings:

Treatment ongoing for approximately 42 months with partial response in a TKI pre-treated patient with an inflammatory myofibroblastic tumor;
Treatment ongoing for approximately 13 months with partial response in a TKI-naïve patient with metastatic colorectal cancer previously treated with standard of care chemotherapy; and,
Treatment ongoing for approximately 19 months with partial response in a TKI-naïve patient with cholangiocarcinoma previously treated with standard of care chemotherapy.
Among these 15 patients, zidesamtinib was observed to be generally well-tolerated with only one dose reduction due to treatment-related adverse events (TRAEs) and no discontinuations due to TRAEs or treatment-emergent adverse events as of the data cutoff date. The preliminary overall safety profile was consistent with its ROS1-selective, TRK-sparing design, and with previously reported data.

Enrollment is ongoing in the global Phase 2 cohort of the ARROS-1 trial for adult and adolescent patients with advanced ROS1-positive solid tumors other than NSCLC.

About Neladalkib
Neladalkib is an investigational, brain-penetrant, ALK-selective inhibitor created with the aim to overcome limitations observed with currently available ALK inhibitors. Neladalkib is designed to remain active in tumors that have developed resistance to first-, second-, and third-generation ALK inhibitors, including tumors with single or compound treatment-emergent ALK mutations such as G1202R. In addition, neladalkib is designed for central nervous system (CNS) penetrance to improve treatment options for patients with brain metastases, and to avoid inhibition of the structurally related tropomyosin receptor kinase (TRK) family. Together, these characteristics have the potential to avoid TRK-related CNS adverse events seen with dual TRK/ALK inhibitors and to drive deep, durable responses for patients across all lines of therapy. Neladalkib has received breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with locally advanced or metastatic ALK-positive non-small cell lung cancer (NSCLC) who have been previously treated with 2 or more ALK tyrosine kinase inhibitors and orphan drug designation for ALK-positive NSCLC.

About Zidesamtinib
Zidesamtinib is an investigational, brain-penetrant, ROS1-selective inhibitor created with the aim to overcome limitations observed with currently available ROS1 inhibitors. Zidesamtinib is designed to remain active in tumors that have developed resistance to currently available ROS1 inhibitors, including tumors with treatment-emergent ROS1 mutations such as G2032R. In addition, zidesamtinib is designed for central nervous system (CNS) penetrance to improve treatment options for patients with brain metastases, and to avoid inhibition of the structurally related tropomyosin receptor kinase (TRK) family. Together, these characteristics have the potential to avoid TRK-related CNS adverse events seen with dual TRK/ROS1 inhibitors and to drive deep, durable responses for patients across all lines of therapy.

Based on results for tyrosine kinase inhibitor (TKI) pre-treated patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) enrolled in the global, single-arm, registrational ARROS-1 Phase 1/2 clinical trial, the U.S. Food and Drug Administration (FDA) has accepted for filing Nuvalent’s NDA submission for zidesamtinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who received at least 1 prior ROS1 TKI. The application has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 18, 2026. Zidesamtinib has received breakthrough therapy designation for the treatment of patients with ROS1-positive metastatic NSCLC who have been previously treated with 2 or more ROS1 TKIs and orphan drug designation for ROS1-positive NSCLC.

(Press release, Nuvalent, MAY 21, 2026, View Source [SID1234665958])

On May 21, 2026 Physician-scientists from Rutgers Cancer Institute and RWJBarnabas Health reported that it will present practice-changing research and emerging treatment approaches across a range of cancer types at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 29–June 2 in Chicago and online. Highlights include findings from a late-breaking abstract, Neo-adjuvant rilvegostomig (R) + trastuzumab deruxtecan (T-DXd) in high-risk HER2-negative breast cancer: Results from the I-SPY 2.2 trial, scheduled for presentation on June 1 at 10:45 a.m. CDT.

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Rutgers Cancer Institute, New Jersey’s only National Cancer Institute-designated Comprehensive Cancer Center, together with RWJBarnabas Health, will have a significant presence at this year’s meeting with 39 accepted peer-reviewed scientific abstracts, including one late-breaking session and a combination of oral and poster presentations, a clinical science symposium, an education session and panel Q&A.

"Advances in cancer care are increasingly defined by how effectively we can translate scientific discovery into meaningful impact for patients," said Steven K. Libutti, MD, FACS, William N. Hait Director, Rutgers Cancer Institute and Senior Vice President, Oncology Services, RWJBarnabas Health. "The research being presented at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting reflects the expertise and leadership of our world-class physician-scientists and multidisciplinary teams, whose work continues to advance innovation in cancer care. From early detection to novel therapies and clinical insights, we are leveraging data, technology and collaboration to deliver more personalized and accessible care for patients. Building on the capabilities of the Jack & Sheryl Morris Cancer Center, New Jersey’s only freestanding cancer hospital, we are creating greater opportunities for patients to access the latest treatments, clinical trials and specialized cancer care closer to home."

The research accepted for presentation at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting exemplifies the breadth and impact of our oncology program and includes studies across breast, colorectal, pancreatic, and other cancer types.

Key scientific contributions from Rutgers Cancer Institute and RWJBarnabas Health at ASCO (Free ASCO Whitepaper) 2026:

ABSTRACT 7009: Researchers reported results from Part 1B of the Phase 3 OLYMPIA-3 study evaluating odronextamab (ODRO) plus Chemotherapy (CHOP) in patients with previously untreated diffuse large B-cell lymphoma with high-risk features. Among 40 patients randomized to two dosing regimens, the safety profile was generally manageable and similar across groups. Findings show encouraging preliminary efficacy with no meaningful differences between regimens, and the less frequent dosing schedule was selected as the recommended Phase 3 dose for the next stage of the study.

EDUCATION SESSION: Researchers reviewed the evidence and rationale for the early integration of palliative care (EPC) alongside disease-directed treatment in patients with metastatic castration-resistant prostate cancer. EPC is delivered by an interdisciplinary team and focuses on symptom management, psychosocial support, communication and shared decision-making, and future planning, including advance care planning. The review highlights evidence showing that early palliative care can improve quality of life, reduce symptom burden, improve mood, and reduce aggressive end-of-life care. The authors also note that prostate cancer’s long disease trajectory and cumulative treatment-related morbidity make it especially suited to early palliative involvement.
ABSTRACT 7093: A multivariable analysis of overall survival was conducted from the Phase 3 SUNMO, STARGLO, and POLARGO trials in patients with relapsed/refractory large B-cell lymphoma and evaluated combination therapies versus rituximab plus chemotherapy. The analyses showed that after adjusting for baseline differences, all three studies demonstrated favorable overall survival with adjusted hazard ratios ≤0.65 versus rituximab plus chemotherapy. The pooled analysis further supported the overall survival benefit of mosunetuzumab plus polatuzumab vedotin compared with the control treatment.

ABSTRACT 12038: The HERO trial evaluated Tai Chi Qigong (TCQ) for its effects on fatigue-related gene expression profiles compared with an exercise-intensity matched intervention and usual care. Among the 113 participants, TCQ favorably regulated genes involved in inflammation, metabolite sensing, and energy activation pathways at 3 months. These findings suggest that TCQ produced meaningful changes in inflammatory, adrenergic, energy and metabolic pathways, supporting potential biological mechanisms behind its effects on cancer-related fatigue.
The full list of presentations from Rutgers Cancer Institute and RWJBarnabas Health at this year’s 2026 ASCO (Free ASCO Whitepaper) Annual Meeting can be found here.

(Press release, Rutgers Cancer Institute of New Jersey, MAY 21, 2026, View Source [SID1234665957])

On May 21, 2026 AbbVie (NYSE: ABBV) reported that it will present new data at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago demonstrating the depth and breadth of its oncology pipeline. The data will be shared through multiple oral presentations and posters spanning solid tumors and blood cancer indications.

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Collectively, these presentations highlight AbbVie’s continued focus on attacking cancer from inside and outside the cell, supported by sustained investment in its expanding antibody‑drug conjugate (ADC) platform, including Topoisomerase I inhibitor (Top1i)–based ADCs and its T‑cell engager (TCE) portfolio.

"Our oncology pipeline is intentionally designed to address the complexity and heterogeneity of cancer biology through a diversified portfolio of differentiated therapies spanning multiple modalities," said Daejin Abidoye, M.D., vice president, therapeutic area head, oncology, solid tumor and hematology. "The data we are presenting at ASCO (Free ASCO Whitepaper) reflect the strength of this strategy, including continued momentum with our ADC programs in solid tumors and validation of immune-based approaches, such as etentamig, being investigated as a next-generation TCE in multiple myeloma. These results underscore our commitment to advancing assets with distinct scientific approaches aimed to address critical unmet patient needs."

Key findings presented include:

Data from AbbVie’s Top1i ADCs Across Solid Tumors:

Metastatic castration-resistant prostate cancer (mCRPC): A first-in-human Phase 1 study (NCT06318273) evaluating ABBV-969, a potential first-in-class bispecific ADC targeting PSMA/STEAP1, in heavily pretreated patients with mCRPC, demonstrated a confirmed objective response rate (ORR) of 45% among 29 patients with RECIST-evaluable disease. At active dose levels, 67% of patients achieved at least a 50% reduction in prostate-specific antigen (PSA50), with 28% achieving PSA90 responses. The safety profile was manageable in heavily pretreated patients with mCRPC.1 Additional findings to be presented at the meeting.
Small cell lung cancer (SCLC): In Phase 1 data (NCT05599984) of ABBV-706 (SEZ6-directed ADC) in the monotherapy cohort (n=17), SCLC patients receiving ABBV-706 at the recommended Phase 3 dose of 1.8 mg/kg as a second-line therapy achieved an objective response rate (ORR) of 82%— promising data in a disease where prognosis remains poor. The safety profile was comparable with previously reported data.2 Additional findings and updated data will be presented at the meeting. The findings support continued evaluation of ABBV-706 in SCLC.
Platinum-resistant ovarian cancer (PROC) and head and neck squamous cell carcinoma (HNSCC): Data from a Phase 1 basket study of Telisotuzumab adizutecan (Temab-A), a next-generation c-Met–directed ADC, demonstrated antitumor activity of Temab-A monotherapy in biomarker unselected PROC (NCT06084481) and HNSCC (NCT06084481) patients.3,4
Additional observations in c-Met selected patients, to be presented at the meeting, highlight the potential of Temab-A in this population.3,4
These new data support the potential of Temab-A across an expanding range of solid tumors and patient populations, including previously presented data in lung, colorectal and gastric cancers and across patients with MET-amplification and increased c-Met expression.
Relapsed/refractory multiple myeloma (R/R MM): Data from a Phase 1b study of etentamig (NCT05650632), being investigated as a next-generation B-cell maturation antigen (BCMA) x CD3 T-cell engager, as monotherapy in a cohort of heavily pre-treated BCMA-exposed R/R MM patients will be presented at the meeting.
Etentamig is an investigational BCMA and CD3 bispecific antibody T-cell engager composed of bivalent BCMA-binding domains allowing for high BCMA-avidity and a low-affinity CD3 binding domain.
The data showed that among patients (n=11) that proceeded to etentamig after BCMA-directed CAR-T in the prior line of therapy, an ORR of 64% was achieved. Minimal residual disease (MRD) negativity was observed in 67% (2/3) of evaluable patients who received BCMA-directed therapy in the prior line of therapy. The median duration of response was 13 months. No new safety signals were observed. Despite no step-up dosing (SUD) in this cohort, all cytokine release syndrome (CRS) reported (57%) were grade 1 and 2.5 Additional findings to be presented at the meeting.
Further information on AbbVie clinical trials is available at View Source

Additional details on key presentations are available below, and the full ASCO (Free ASCO Whitepaper) Annual Meeting 2026 abstracts are available here.

Title

Date/Time

Session

Abstract
Number

Etentamig in patients (pts) with
relapsed/refractory multiple
myeloma (RRMM) with prior
exposure to B-cell maturation
antigen (BCMA)-targeted therapy.

Friday,

May 29

5:09-5:21
PM CDT

Oral Presentation

Oral Abstract
Session

Hematologic

Malignancies—
Plasma Cell

Dyscrasia

7508

Phase 1 basket study of
telisotuzumab adizutecan
(Temab-A, ABBV-400), a

c-Met protein-targeting antibody-
drug conjugate: Results from
patients with platinum-resistant
ovarian/primary
epithelial/fallopian tube cancer
(PROC).

Saturday,
May 30

8:42-8:48
AM CDT

Rapid Oral
Abstract Session

Gynecologic
Cancer

5514

A phase 2 randomized study
comparing telisotuzumab
adizutecan monotherapy with
standard of care in patients with
post-adjuvant circulating tumor
DNA-positive colorectal cancer.

Saturday,
May 30

9:00 AM-
12:00 PM
CDT

Poster Board:
447a

Poster Session

Gastrointestinal
Cancer—Colorectal
and Anal

TPS3688

A Phase 2 study of telisotuzumab
adizutecan (ABBV-400; Temab-A)
in patients with advanced solid
tumors harboring MET
amplification.

Saturday,
May 30

1:30-4:30
PM CDT

Poster Board:
293a

Poster Session

Developmental
Therapeutics—
Molecularly
Targeted Agents
and Tumor Biology

TPS3157

Phase 1 basket study of
telisotuzumab adizutecan (ABBV-
400, Temab-A), a c-Met protein-
targeting antibody-drug
conjugate: Results from patients
with head and neck squamous
cell carcinoma (HNSCC).

Saturday,
May 30

1:30-4:30
PM CDT

Poster Board:
484

Poster Session

Head and Neck
Cancer

6027

Telisotuzumab adizutecan
(Temab-A) plus osimertinib (osi)
as 1L treatment for
unresectable/metastatic NSCLC.

Sunday,
May 31

9:00 AM-
12:00 PM
CDT

Poster Board:
451a

Poster Session

Lung Cancer—

Non-Small Cell
Metastatic

TPS8663

Impact of MET amplification
(amp) on telisotuzumab vedotin
(Teliso-V) efficacy and safety in
2L+ non-squamous (NSQ) EGFR
wild-type (WT) NSCLC with c-Met
protein overexpression (OE).

Sunday,
May 31

9:00 AM-
12:00 PM
CDT

Poster Board: 314

Poster Session

Lung Cancer—

Non-Small Cell
Metastatic

8524

AndroMETa-Lung-713: A phase
2/3 study of telisotuzumab
adizutecan (ABBV-400, Temab-A)
vs standard of care (SOC) in
patients with epidermal growth
factor receptor (EGFR)-mutated
non-small cell lung cancer
(NSCLC).

Sunday,
May 31

9:00 AM-
12:00 PM
CDT

Poster Board:
450a

Poster Session

Lung Cancer—

Non-Small Cell
Metastatic

TPS8661

SEZanne: A phase 2 randomized,
open-label, multicenter study to
evaluate the optimal dose, safety,
and efficacy of ABBV-706 in
combination with atezolizumab
(atezo) versus standard of care
(SOC) in patients (pts) with

previously untreated extensive-
stage (ES) small cell lung cancer
(SCLC).

Sunday,
May 31

9:00 AM-
12:00 PM
CDT

Poster Board:
603a

Poster Session

Lung Cancer—Non-
Small Cell Local-
Regional/Small
Cell/Other
Thoracic Cancers

TPS8135

A phase 1, first-in-human (FIH)
study evaluating the safety,
pharmacokinetics, and efficacy of
ABBV-969 in patients with
metastatic castration-resistant
prostate cancer (mCRPC).

Sunday,

May 31

4:42-4:48
PM CDT

Rapid Oral
Abstract Session

Genitourinary

Cancer—Prostate,
Testicular,

and Penile

5014

A single-arm, phase 2 study of
neoadjuvant mirvetuximab
soravtansine and carboplatin for
FRα-expressing advanced-stage
serous epithelial ovarian, fallopian
tube, or primary peritoneal cancer
(M25-231; NCT06890338; GOG-

3115).

Monday,
June 1

9:00 AM-
12:00 PM
CDT

Poster Board:
296b

Poster Session

Gynecologic
Cancer

TPS5633

ABBV-706 as monotherapy and in
combination with budigalimab in
patients with relapsed/refractory
(R/R) small cell lung cancer (SCLC).

Monday,

June 1

3:39-3:51
PM CDT

Oral Presentation

Oral Abstract
Session

Lung Cancer—Non-
Small Cell Local-
Regional/Small
Cell/Other
Thoracic Cancers

8008

Phase 1, first-in-human (FIH)
study evaluating safety and
efficacy of ABBV-706: Results
from patients with high-grade
central nervous system (CNS)
tumors.

Monday,

June 1

1:30-4:30
PM CDT

Poster Board: 406

Poster Session

Central Nervous
System Tumors

2041

A US-based, retrospective,
observational study of biomarker
testing patterns across lines of
therapy in patients with
metastatic colorectal cancer.

N/A

Publication Only

Gastrointestinal
Cancer –
Colorectal and
Anal

e15526

Timing of biomarker testing and
associated clinical outcomes in
ovarian cancer patients: A
retrospective study.

N/A

Publication Only

Gynecologic
Cancer

e17574

Real-world (RW) characteristics
and outcomes in platinum-
resistant ovarian cancer (PROC)
patients treated with
mirvetuximab soravtansine
(MIRV) monotherapy or single-
agent chemotherapy (CTx).

N/A

Publication Only

Gynecologic
Cancer

e17606

Telisotuzumab adizutecan (Temab-A), etentamig, ABBV-969, and ABBV-706 are investigational medicines and are not approved by any health authorities worldwide. The safety and efficacy of these investigational medicines are under evaluation as part of ongoing clinical studies.

U.S. Prescribing Information for AbbVie Medicines

Please see full Prescribing Information for ELAHERE (mirvetuximab soravtansine-gynx)
Please see full Prescribing Information for EMRELIS (telisotuzumab vedotin-tllv)
Please see full Prescribing Information for EPKINLY (epcoritamab -bysp)

(Press release, AbbVie, MAY 21, 2026, View Source [SID1234665956])

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])

On May 21, 2026 Kelun reported two registrational studies of the trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT)(佳泰莱) and the next‑generation selective rearranged during transfection (RET) inhibitor lunbotinib fumarate (A400/EP0031,宁泰莱) from Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK) have been selected for oral presentation session on Lung Cancer – Non-Small Cell Metastatic. The full text of the related abstracts were published on the ASCO (Free ASCO Whitepaper) official website[2] on May 21, 2026, local time. Key highlights are summarized as follows:

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Study 1

Sacituzumab tirumotecan (sac-TMT) plus pembrolizumab versus pembrolizumab as first-line treatment for PD-L1 positive advanced non-small cell lung cancer (NSCLC): Results from the randomized, controlled Phase III OptiTROP-Lung05 study, to be presented as an oral presentation scheduled on May 29, 2026, 3:12 PM-3:24 PM CDT (Abstract #8506: Lung Cancer – Non-Small Cell Metastatic)

A total of 413 patients with previously untreated locally advanced or metastatic NSCLC without epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) alterations and with programmed death ligand 1 (PD-L1) positive (defined as tumor proportion score (TPS) ≥1%), covering both squamous and non‑squamous histologies, were enrolled and randomized (1:1) to receive sac-TMT (4mg/kg Q2W) plus pembrolizumab (400mg Q6W) or pembrolizumab monotherapy (400mg Q6W). The primary endpoint was progression‑free survival (PFS) assessed by blinded independent central review (BICR), and the key secondary endpoint was overall survival (OS). As of September 29, 2025, the median follow-up was 10.5 months.

The results demonstrated that：

Significant PFS improvement: PFS assessed by BICR was significantly improved in the sac-TMT plus pembrolizumab group compared with the pembrolizumab group, with a median PFS of not reached (NR) versus 5.7 months (hazard ratio (HR)=0.35; 95% confidence interval (CI): 0.26–0.47; p<0.0001).
Substantially higher response rate: The objective response rate (ORR) assessed by BICR was 70.2% in the sac-TMT plus pembrolizumab group versus 42.0% in the pembrolizumab group.
Positive OS trend though immature (HR=0.55; 95% CI: 0.36–0.85).
Consistent benefit across prespecified subgroups: the HR for PFS in patients with PD-L1 TPS 1-49% and TPS ≥ 50% were 0.28 (95% CI, 0.19-0.41) and 0.47 (95% CI, 0.29-0.77), respectively; the HR for PFS in patients with non-squamous and squamous NSCLC were 0.28 (95% CI, 0.18-0.43) and 0.44 (95% CI, 0.29-0.66).
In terms of safety, grade≥ 3 treatment-emergent adverse events (TEAEs) occurred in 55.3% of patients in the sac-TMT plus pembrolizumab group versus 31.4% in the pembrolizumab group. TEAEs leading to permanent discontinuation of sac-TMT and pembrolizumab occurred in 3.8% and 5.3% of patients, respectively, while TEAEs leading to permanent discontinuation occurred in 4.9% of patients in the pembrolizumab group.

OptiTROP-Lung05 is the first Phase III clinical study demonstrating a significant improvement in PFS and a positive trend in OS with an ADC combined with pembrolizumab compared to pembrolizumab in first-line treatment for PD-L1 positive advanced NSCLC. Based on these results, a supplemental New Drug Application (sNDA) for this combination regimen has been accepted for review and included in the priority review and approval process by the National Medical Products Administration (NMPA) in China.

Study 2

Efficacy and safety of lunbotinib (A400/EP0031), a next-generation selective RET inhibitor (SRI), from a pivotal phase Ⅱ study in patients with advanced RET-fusion positive non-small cell lung cancer (NSCLC), to be presented as an oral presentation scheduled on May 29, 2026, 2:36 PM-2:48 PM CDT (Abstract #8505: Lung Cancer – Non-Small Cell Metastatic)

As of October 29, 2025, 71 patients with prior platinum-based chemotherapy and immunotherapy (pre-treated patients) and 92 patients who had not received prior systemic therapy (treatment-naïve patients) were enrolled, with median follow-up of 22.6 and 20.7 months.

The study demonstrated that：

Independent Review Committee (IRC)-assessed confirmed ORR was 87.1% (95% CI: 77.0-93.9) in pre-treated patients and 81.3% (95% CI: 71.8-88.7) in treatment-naïve patients;
Median PFS was 27.5 months in pre-treated patients (immature) and NR in treatment-naïve patients, with 24-month PFS rates of 52.1% and 59.9%, respectively;
Median OS was not reached in either group, with 24-month OS rates of 65.7% in pre-treated patients and 74.1% in treatment-naïve patients.
Among patients with baseline brain metastases (23 pre-treated, 16 treatment-naïve), ORR was 82.6% and 75.0%, respectively, and 6 patients in each cohort had complete intracranial response.
The safety profile was manageable, with no new signals identified. Grade ≥ 3 treatment-related adverse events (TRAEs) occurred in 40.5% of patients. Only two patients (1.2%) permanently discontinued treatment due to TRAEs. No fatal TRAEs occurred.

Based on the results of this study, the new drug application (NDA) for lunbotinib fumarate for the treatment of adult patients with RET fusion-positive locally advanced or metastatic NSCLC has been accepted for review by the NMPA.

About sac-TMT(佳泰莱)

Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), gynecological tumors and genitourinary tumors, among others. Sac-TMT is developed with a unique, bifunctional linker that maximizes payload delivery to tumor cells both through its irreversible connection with the anti-TROP2 monoclonal antibody sacituzumab and its pH-sensitive cleavage from a belotecan-derivative topoisomerase I inhibitor payload in the lysosome, with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases the payload KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.

In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macao and Taiwan).

To date, four indications for sac-TMT have been approved and marketed in China for: 1) unresectable locally advanced or metastatic triple‑negative breast cancer (TNBC) who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting); 2) EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR–tyrosine kinase inhibitor (EGFR-TKI) therapy and platinum-based chemotherapy; 3) EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC who progressed after treatment with EGFR-TKI therapy; 4) unresectable or metastatic hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) (Immunohistochemistry (IHC) 0, IHC 1+ or IHC 2+/In Situ Hybridization (ISH)-) BC who have received prior endocrine therapy and at least one line of chemotherapy in advanced setting. The first two indications above have been included in China’s National Reimbursement Drug List (NRDL). This inclusion is expected to bring clinically meaningful benefits to a greater number of patients with BC and NSCLC. Additionally, sac-TMT has been granted six Breakthrough Therapy Designations (BTDs) by the NMPA.

Sac-TMT is the world’s first TROP2 ADC drug approved for marketing in lung cancer. A new indication application for sac-TMT in combination with pembrolizumab (KEYTRUDA[3]) as first‑line treatment for locally advanced or metastatic NSCLC who have PD-L1 TPS≥1% and are EGFR-negative and ALK-negative has been accepted for review by the NMPA, and has entered the priority review and approval process. As of today, Kelun-Biotech has initiated 9 registrational clinical studies in China. MSD is evaluating 17 ongoing global Phase III clinical studies of sac-TMT as a monotherapy or in combination with pembrolizumab or other anti-cancer agents for several types of cancer. These studies are sponsored and led by MSD.

[1] Trade name to be approved by NMPA.

[2] View Source

[3] KEYTRUDA (pembrolizumab) is a registered trademark of Merck Sharp & Dohme LLC (MSD), a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About Lunbotinib Fumarate (A400/EP0031,宁泰莱)

Lunbotinib fumarate is a novel, next-generation selective RET inhibitor for NSCLC, medullary thyroid cancer (MTC) and other solid tumors with a high prevalence of RET alterations. The NDA of lunbotinib fumarate has been accepted for review by the NMPA of China for the treatment of adult patients with RET-fusion positive locally advanced or metastatic NSCLC. The Company is also conducting a Phase Ib/II clinical study in China for the treatment of RET-positive solid tumors.

In March 2021, the Company granted Ellipses Pharma Limited, a U.K.-based international oncology drug development company, an exclusive license to develop, manufacture and commercialize this agent outside Greater China and certain Asian countries. In April 2024, lunbotinib fumarate was cleared by the Food and Drug Administration (FDA) to progress into a Phase II clinical trial (NCT05443126) which is currently recruiting in the United States, United Kingdom, Europe and United Arab Emirates, where it is being evaluated as a monotherapy and in combination with chemotherapy in RET fusion positive advanced NSCLC.

(Press release, Kelun, MAY 21, 2026, View Source [SID1234665954])