On May 31, 2026 Incyte (Nasdaq:INCY) reported positive results from the pivotal Phase 3 frontMIND trial evaluating the efficacy and safety of tafasitamab (Monjuvi/Minjuvi), a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody, and lenalidomide added to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone; Tafa-Len-R-CHOP) versus R-CHOP alone as a first-line treatment for adults with previously untreated diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL). Eligible patients had an International Prognostic Index (IPI) score of 3-5, or, for patients ≤60 years of age, an age-adjusted IPI (aaIPI) of 2-3.

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The oral presentation of these data is taking place at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held May 29 – June 2, 2026, in Chicago (Abstract #LBA7000. Session: Oral Abstract Session – Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia. May 30, 4:00 – 7:00 p.m. ET [3:00 – 6:00 p.m. CDT]) with simultaneous publication in The Lancet*.

"The Phase 3 frontMIND results mark a potential inflection point in the treatment of patients with previously untreated, high-risk DLBCL and HGBL, where outcomes have remained largely unchanged for decades," said Steven Stein, M.D., Executive Vice President, Chief Medical Officer and Head of Late-stage Development, Incyte. "These findings support Tafa-Len-R-CHOP as a potential new standard of care option in the first-line treatment of DLBCL, with benefit observed across both cell-of-origin (COO) molecular subtypes, and we look forward to advancing our global regulatory filings as we seek to bring this option to patients."

The results build on previously reported topline data indicating the trial met its primary endpoint of progression-free survival (PFS) by investigator assessment.

The data demonstrate that Tafa-Len-R-CHOP resulted in a statistically significant and clinically meaningful improvement in PFS, with a 25% reduction in risk of disease progression or death among patients treated with Tafa-Len-R-CHOP compared with R-CHOP alone (HR 0.75 [P=0.0194]; 95% CI, 0.59–0.96; median follow-up of 35.2 months).

A PFS increase of 8.2% was seen at 2 years (71.1% with Tafa-Len-R-CHOP vs 62.9% with R-CHOP).
A PFS increase of 6.6% was seen at 3 years (67.3% with Tafa-Len-R-CHOP vs 60.7% with R-CHOP).
Additionally, point estimates suggested trends toward PFS advantage with Tafa-Len-R-CHOP are broadly consistent across prespecified subgroups, including patients with centrally confirmed lymphoma subtypes and across COO molecular subtypes (ABC [Activated B-cell-like] and GCB [Germinal Center B-cell-like]).
Treatment with Tafa-Len-R-CHOP also significantly improved the key secondary endpoint of event-free survival (EFS) compared to R-CHOP alone (HR 0.79 [P=0.0260] 95% CI, 0.64-0.97; median follow-up of 35.4 months). Additionally, interim overall survival (OS) analysis demonstrated a positive trend toward improvement (HR=0.85 [P=0.2703] 95% CI, 0.63–1.14, median follow-up of 35.9 months), with final analysis planned after additional follow-up.

"For years, R-CHOP has remained the standard first-line therapy for DLBCL, yet nearly 40% of patients experience disease progression or relapse after initial treatment, underscoring the need for innovation," said Dr. Georg Lenz, University Hospital Münster and principal investigator of the frontMIND study. "The frontMIND study shows that adding tafasitamab and lenalidomide to R-CHOP improved outcomes, including in patients with high-risk disease, who have historically faced poor prognoses and limited treatment options. These results suggest that this regimen could help broaden the first-line treatment options for this patient population."

Tafa-Len-R-CHOP was generally well tolerated, and safety was consistent with the expected safety profile of adding Tafa-Len to R-CHOP.

The most common treatment-emergent adverse events (TEAEs) in the Tafa-Len-R-CHOP group were neutropenia (70.7%), anemia (46.3%) and peripheral neuropathy (40.6%). Any grade TEAEs were similar in both treatment arms (98.6% vs 97.1%). More Grade ≥3 TEAEs occurred with Tafa-Len-R-CHOP (86.7%) vs R-CHOP alone (76.1%). The most common Grade 3 TEAEs in the Tafa-Len-R-CHOP group were anemia (22.8%), thrombocytopenia (13.1%) and neutropenia (12.4%). The most common Grade 3 TEAEs with R-CHOP alone were anemia (15.9%), febrile neutropenia (8.7%) and thrombocytopenia (6.7%).

Importantly, the incremental safety events observed with Tafa-Len-R-CHOP were well managed and did not interfere with the delivery of the R-CHOP backbone. Rates of TEAEs leading to discontinuation of all study treatment were similar between the two groups (5.2% for Tafa-Len-R-CHOP and 5.4% for R-CHOP alone). Although a higher rate of fatal TEAEs was observed with Tafa-Len-R-CHOP (5.9% vs 3.8% with R-CHOP), there were fewer overall deaths with Tafa-Len-R-CHOP (82 [18.5%]) compared to R-CHOP (97 [21.7%]), consistent with the positive trend observed in OS.

The frontMIND data support the submission of global regulatory applications for tafasitamab and lenalidomide in addition to R-CHOP for previously untreated DLBCL.

About Diffuse Large B-cell Lymphoma (DLBCL)
Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma (NHL) in adults worldwide, representing 40% of all cases.1 It is characterized as an aggressive, fast-growing type of lymphoma that can emerge in lymph nodes or extranodal sites such as the gastrointestinal tract, skin and brain.2 Each year, approximately 24,000 people in the U.S. and up to 36,000 people in Europe are diagnosed with DLBCL.3,4 With about 40% of these patients not responding to initial therapy or relapsing thereafter,5,6 there is a high medical need for new, effective therapies, particularly for high-risk patients.

About frontMIND
The frontMIND trial (NCT04824092) is a randomized, double-blind, placebo-controlled, global Phase 3 study in patients with previously untreated high-risk diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL).

The study enrolled 899 adults (≥18 to ≤80 years) and is evaluating the efficacy and safety of tafasitamab and lenalidomide added to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) compared with R-CHOP alone.

The primary endpoint of the study is investigator-assessed progression-free survival (PFS) using the Lugano 2014 criteria. Key secondary endpoints include event-free survival (EFS) by investigator assessment and overall survival (OS).

For more information about the frontMIND trial, please visit View Source

About Tafasitamab (Monjuvi/Minjuvi)
Tafasitamab (Monjuvi/Minjuvi) is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). Incyte licenses exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc.

In the U.S., Monjuvi (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). Additionally, Monjuvi received accelerated approval in the United States in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).

Monjuvi is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.

In Europe, Minjuvi (tafasitamab) received conditional Marketing Authorization from the European Medicines Agency (EMA) in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT. In addition, in December 2025, the EMA approved Minjuvi, in combination with lenalidomide and rituximab, for the treatment of adult patients with relapsed or refractory FL (Grade 1-3a) after at least one line of systemic therapy.

In Japan, Minjuvi is approved in combination with rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma (2L+ FL).

XmAb is a registered trademark of Xencor, Inc.

Monjuvi and Minjuvi are registered trademarks of Incyte.

IMPORTANT SAFETY INFORMATION

What are the possible side effects of MONJUVI?
MONJUVI may cause serious side effects, including:

Infusion reactions. Your healthcare provider will monitor you for infusion reactions during your infusion of MONJUVI. Tell your healthcare provider right away if you get fever, chills, flushing, headache, or shortness of breath during an infusion of MONJUVI.
Low blood cell counts (platelets, red blood cells, and white blood cells). Low blood cell counts are common with MONJUVI, but can also be serious or severe. Your healthcare provider will monitor your blood counts during treatment with MONJUVI. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or any bruising or bleeding.
Infections. Serious infections, including infections that can cause death, have happened in people during treatment with MONJUVI and after the last dose. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or develop any signs and symptoms of an infection.
The most common side effects of MONJUVI include:

Feeling tired or weak
Diarrhea
Cough
Fever
Swelling of lower legs or hands
Respiratory tract infection
Decreased appetite
These are not all the possible side effects of MONJUVI. Your healthcare provider will give you medicines before each infusion to decrease your chance of infusion reactions. If you do not have any reactions, your healthcare provider may decide that you do not need these medicines with later infusions. Your healthcare provider may need to delay or completely stop treatment with MONJUVI if you have severe side effects.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before you receive MONJUVI, tell your healthcare provider about all of your medical conditions, including if you:

Have an active infection or have had one recently.
Are pregnant or plan to become pregnant. MONJUVI may harm your unborn baby. You should not become pregnant during treatment with MONJUVI. Do not receive treatment with MONJUVI in combination with lenalidomide if you are pregnant because lenalidomide can cause birth defects and death of your unborn baby.
You should use an effective method of birth control (contraception) during treatment and for at least 3 months after your final dose of MONJUVI.
Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with MONJUVI.
Are breastfeeding or plan to breastfeed. It is not known if MONJUVI passes into your breastmilk. Do not breastfeed during treatment for at least 3 months after your last dose of MONJUVI.
You should also read the lenalidomide Medication Guide for important information about pregnancy, contraception, and blood and sperm donation.

Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Please see the full Prescribing Information for Monjuvi, including Patient Information, for additional Important Safety Information.

(Press release, Incyte, MAY 31, 2026, View Source [SID1234666279])

On May 31, 2026 D3 Bio Inc., a global clinical-stage biotechnology company dedicated to developing innovative oncology therapeutics, reported first-line (1L) clinical data of elisrasib monotherapy and elisrasib in combination with pembrolizumab from an ongoing Phase I/II study of elisrasib (D3S-001), its next-generation KRAS G12C inhibitor, in patients with KRAS G12C mutation–positive (G12Cmut) non–small cell lung cancer (NSCLC). The data were presented in a Clinical Science Symposium at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois.

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Findings from both cohorts, which demonstrate favorable safety and tolerability profiles along with highly promising antitumor activity in 1L G12Cmut NSCLC across all levels of PD-L1 expression, support continued evaluation of elisrasib in the first-line setting.

Elisrasib as First-Line Monotherapy for Patients with KRAS G12C Mutation–Positive NSCLC

Elisrasib monotherapy demonstrated highly promising preliminary antitumor activity. Forty-three patients with previously untreated G12Cmut NSCLC received elisrasib 600 mg once daily in 21-day cycles, with a median study follow-up of 8.5 months. In 41 efficacy-evaluable patients, the overall response rate (ORR) was 78.0% was observed across all levels of PD-L1 expression, with 76.2% ORR in patients with PD-L1 TPS <1% (N=21) and 80.0% in patients with PD-L1 TPS of ≥1% (N=20), respectively. The disease control rate (DCR) was 95.1%. The median progression-free survival (mPFS) was 12.4 months (95% CI: 6.8, NR), with a 12-month PFS rate of 50.8%. Median overall survival (OS) was not reached, with a 12-month OS rate of 90.0%. As of the data cutoff, 60.5% of patients remained on study treatment.

Elisrasib monotherapy was well tolerated, with Grade 3 or higher TRAEs observed in only 7% of patients and serious TRAEs in 2.3% of patients. No TRAEs led to elisrasib discontinuation, and no dose reductions were required.

Elisrasib plus Pembrolizumab as First-Line Combination Therapy for Patients with KRAS G12C Mutation–Positive NSCLC

Fifty-two patients with previously untreated G12Cmut NSCLC received elisrasib 600 mg once daily in combination with pembrolizumab 200 mg every 3 weeks (Q3W), with a median study follow-up of 5.7 months. Notably, the dose of elisrasib used in combination is elisrasib’s RP2D at 600mg QD which provides complete KRAS G12C target coverage.

The combination of elisrasib and pembrolizumab showed highly compelling antitumor activity in patients with previously untreated G12Cmut NSCLC. In 48 efficacy-evaluable patients, an ORR 81.3% was observed across all PD-L1 expression levels, with ORR of 70.6% in patients with PD-L1 TPS <1% (N=17), 72.7% in patients with PD-L1 TPS of 1% to 49% (N=11), and 95.0% in patients with PD-L1 TPS ≥50% (N=20), respectively. The overall DCR was 97.9%. The median PFS was not reached (95% CI: 8.4, NR), with a 6-month PFS rate of 74.6% and a 12-month PFS rate of 53.7%. Median OS was not reached, with a 12-month OS rate of 88.8%. As of the data cutoff, 82.7% of patients remained on study treatment.

The combination regimen demonstrated a safety profile consistent with the known profiles of each agent. Grade 3 or higher TRAEs occurred in 32.7% of patients, with most severe events attributable to pembrolizumab, and serious TRAEs reported in 17.3% of patients. No new or unexpected safety signals were identified for elisrasib, and the overall safety profile compared favorably with the established standard-of-care regimen of pembrolizumab plus chemotherapy.

Expert Commentary

Prof. Shun Lu, M.D., Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, and lead study presenter, said: "The first-line results for elisrasib are very encouraging, showing strong and consistent antitumor activity across PD-L1 expression subgroups, both monotherapy and in combination with pembrolizumab. Its favorable tolerability and rapid response onset further highlight its potential as a promising treatment option for patients with KRAS G12C-mutant NSCLC."

"The compelling activity of elisrasib as monotherapy and in combination with pembrolizumab observed in the first-line NSCLC represents an exceptionally promising signal in this historically difficult-to-treat population," said Dr. George Chen, Founder, Chairman, and Chief Executive Officer of D3 Bio. "We believe these results support the continued and accelerated evaluation of elisrasib in Phase 3 randomized studies."

About Elisrasib (D3S-001)

Elisrasib is a next-generation KRAS G12C inhibitor designed for rapid, complete, and selective target engagement. It covalently binds the GDP-bound (OFF) form of KRAS G12C, effectively blocking nucleotide cycling and suppressing oncogenic signaling. Preclinical studies show robust potency, complete KRAS G12C engagement at clinically relevant exposures, and CNS penetration capability. Elisrasib is currently being evaluated globally in a Phase 2 monotherapy and combination trial across KRAS G12C–mutant solid tumors including NSCLC, CRC, and others.

(Press release, D3 Bio, MAY 31, 2026, View Source [SID1234666264])

On May 31, 2026 Immatics N.V. (NASDAQ: IMTX, "Immatics" or the "Company"), the global leader in precision targeting of PRAME with multiple clinical-stage programs spanning cell therapies and bispecifics, reported the presentation of extended data from the ongoing Phase 1 clinical trial evaluating its TCR bispecific (TCER) candidate IMA401 targeting MAGEA4/8 in heavily pretreated patients with solid tumors, including head and neck cancer and lung cancer, in an oral presentation at the Annual Meeting of the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago, IL, USA. The data show a consistent and favorable tolerability profile across multiple tumor types and encouraging anti-tumor activity at the recommended Phase 2 dose (RP2D) with or without the immune checkpoint inhibitor (ICI) pembrolizumab. Results from the Phase 1 study are being published simultaneously in Nature Medicine.

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Data from the ongoing Phase 1 study of IMA401 will be presented on May 31, 2026, during the Developmental Therapeutics Session – Immunotherapy from 8:00-11:00 am CDT by Martin Wermke, M.D., TU Dresden University of Technology, NCT/UCC Early Clinical Trial Unit, Dresden, Germany (Abstract ID: 2507). The slides are available in the ‘Events & Presentations’ section of the Investor & Media page on the Company’s website.

Carsten Reinhardt, M.D., Ph.D., Chief Development Officer at Immatics, said, "The IMA401 clinical data represent an important step forward for our next-generation, off-the-shelf TCER platform and reinforce the potential of this modality to address both advanced and earlier-stage solid tumors. Building on the encouraging clinical activity and supportive preclinical findings, we believe IMA401 may have even greater potential in combination with IMA402, our PRAME-directed bispecific. The initiation of the IMA401/IMA402 combination cohort in squamous cell non-small cell lung cancer marks a milestone toward broadening patient reach and delivering meaningful clinical benefit for patients with significant unmet needs."

Based on the clinical data for IMA401, including the initial clinical signal in squamous cell non-small cell lung cancer (sqNSCLC), as well as preclinical proof-of-concept data and clinical data for IMA402, Immatics has initiated enrollment in a Phase 1 cohort at multiple clinical trial sites evaluating IMA401 targeting MAGEA4/8 in combination with IMA402 targeting PRAME in sqNSCLC. The dual targeting approach is designed to broaden patient coverage and potentially enhance anti-tumor activity by addressing two highly prevalent cancer targets, with sqNSCLC as the first indication, and further development potential for many others. Based on combined target prevalence, more than 90% of patients with sqNSCLC express PRAME and/or MAGEA4/8. The current addressable patient population for metastatic sqNSCLC in the United States and EU5 is estimated at approximately 40,000 patients per year. First data from the IMA401/IMA402 combination cohort are expected in 2027.

Highlights of Immatics’ clinical data on IMA401

Patient population: Heavily pretreated, highly heterogeneous patient population

As of the data cutoff on March 2, 2026, 61 patients with recurrent and/or refractory solid tumors across >15 different tumor types were treated with IMA401 with or without an immune checkpoint inhibitor (ICI, pembrolizumab) in a Phase 1 dose-escalation basket trial (NCT05359445).
Patients were heavily pretreated with a median of three prior lines of systemic treatment (range: 1-8).
44 patients were treated at RP2D (1-2 mg), with 32 receiving monotherapy and 12 receiving the combination of IMA401 and pembrolizumab. Among these patients, head and neck cancer represented the largest subgroup treated at RP2D (n=14).

Safety: Favorable tolerability at RP2D supporting broad combinability of IMA401

The tolerability profile of IMA401 with or without pembrolizumab was consistent across patient populations.
The most frequent clinically relevant treatment-related adverse events (TRAE) observed across dose levels were low-grade cytokine release syndrome (CRS) (38% G1-2, no ≥ Grade 3), expected and transient lymphopenia (33%), consistent with the mechanism of action, and neutropenia (31%). Within the RP2D range of 1-2 mg, neutropenia was mostly transient and manageable.
Notably, no immune effector cell-associated neurotoxicity syndrome (ICANS) was observed.
Tolerability of IMA401 at RP2D in combination with pembrolizumab was consistent with IMA401 as a monotherapy at RP2D, with no overlapping and/or additive toxicity observed.
Tolerability profile of IMA401, both as a monotherapy and with pembrolizumab, supports broad combination potential of IMA401.

Anti-tumor activity and durability: Promising clinical activity with deep and durable responses
Patients treated with IMA401 at RP2D as a monotherapy or in combination with pembrolizumab demonstrated clinical activity across multiple solid tumor indications, including melanoma, sqNSCLC, head and neck cancer and others:

Head and neck cancer (largest patient subgroup treated at RP2D): confirmed objective response rate (cORR) of 29% (4/14), disease control rate (DCR) of 64% (9/14), median duration of response (mDOR) of 8.8 months. The 12-month overall survival (OS) rate was 63% and the six-month progression-free survival (PFS) rate was 43%. All responders achieved deep tumor reduction ranging from 60-100% and three of four responders were ongoing at data cutoff.
Melanoma: cORR of 33% (2/6), DCR of 67% (4/6); both confirmed responses lasted beyond six months post treatment, with one ongoing for >2.5 years.
sqNSCLC: A presented patient case highlighted a patient with ICI-resistant sqNSCLC who received IMA401 plus pembrolizumab in fifth-line (prior best overall response: stable disease) and achieved a partial response with shrinkage of all target lesions.

Preclinical data: Supporting broad patient coverage and potential synergistic activity of IMA401/IMA402 combination

Target expression data from analyzed tumor samples showed that >90% of patients with sqNSCLC are positive for PRAME and/or MAGEA4/8, and ~60% of patients with sqNSCLC are positive for both targets, suggesting that a combination therapy against both targets could boost anti-tumor activity and counteract potential tumor escape mechanisms.
IMA401/IMA402 combination demonstrated synergistic anti-tumor activity in MAGEA4/8 and PRAME double-positive tumor cell lines.
Data on the IMA401 Phase 1 trial are published simultaneously in Nature Medicine.

About Immatics TCR Bispecifics (TCER)
Immatics’ next-generation half-life extended TCER molecules are antibody-like "off-the-shelf" biologics that leverage the body’s immune system by redirecting and activating T cells towards cancer cells expressing a specific tumor target. The design of the TCER molecules enables the activation of any T cell in the body to attack the tumor, regardless of the T cells’ intrinsic specificity. Immatics’ proprietary biologics are engineered with two binding regions: a TCR domain and a T cell recruiter domain. The TCER format is designed to maximize efficacy while minimizing toxicities in patients. It contains a high-affinity TCR domain that is designed to bind specifically to the cancer target peptide on the cell surface presented by an HLA molecule. The antibody-derived, low-affinity T cell recruiter domain is directed against the TCR/CD3 complex and recruits a patient’s T cells to the tumor to attack cancer cells. With a low-affinity recruiter aiming for optimized biodistribution and enrichment of the molecule at the tumor site instead of the periphery, TCER are engineered to reduce the occurrence of immune-related adverse events, such as cytokine release syndrome. In addition, the TCER format comprises an Fc part that confers half-life extension, stability, and manufacturability. TCER molecules are "off-the-shelf" biologics and thus immediately available for patient treatment. They can be distributed through standard pharmaceutical supply chains and can reach a large patient population without the need for specialized medical centers.

About IMA401 MAGEA4/8 Bispecific
IMA401 is a molecule from Immatics’ TCR bispecifics pipeline that targets an HLA-A*02:01-presented peptide derived from two different cancer-associated proteins, melanoma-associated antigen 4 and/or 8 ("MAGEA4/8"). The MAGEA4/8 peptide has been identified and validated by Immatics’ proprietary mass spectrometry-based target discovery platform XPRESIDENT and is presented at a 5-fold higher target density (copy number per tumor cell) than the MAGEA4 peptide targeted in other clinical trials. IMA401 is currently being evaluated in a Phase 1 basket trial in patients with MAGEA4/8-positive solid tumors. The MAGEA4/8 peptide has a high prevalence in several solid tumor indications such as head and neck squamous cell carcinoma (HNSCC), squamous cell non-small cell lung cancer (sqNSCLC), as well as melanoma and other solid cancer types.

About IMA402 PRAME Bispecific
IMA402 is a molecule from Immatics’ TCR bispecifics (TCER) pipeline directed against an HLA-A*02:01-presented peptide derived from PRAME. IMA402 is currently being evaluated in a Phase 1 trial in patients with solid tumors expressing PRAME. IMA402 is part of Immatics’ strategy to leverage the full clinical potential of targeting PRAME, one of the most promising targets for TCR-based therapies.

(Press release, Immatics, MAY 31, 2026, View Source [SID1234666247])

On May 31, 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) The detailed data was presented today at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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The updated data is from a PoC clinical study conducted in China to evaluate the safety and efficacy of 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 once every 3 weeks, 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).
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 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.
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 occurred in 30.6% of patients treated with 1/1.5 mg/kg and 64.9% of patients treated with 3mg/kg.
The most common adverse events among all patients were arthralgia (52.2%, 3.7% ≥grade 3), anemia (46.3%, 4.4% ≥grade 3), and rash (39.0%, 8.8% ≥grade 3), which were mostly controllable and manageable with mild-to-moderate AEs. No new safety signals were observed.
Professor Jianya Zhou, The First Affiliated Hospital, School of Medicine, Zhejiang University, commented: "Lung cancer remains the most commonly diagnosed and deadliest malignancy worldwide, representing a major public health challenge. Despite the transformative impact of immunotherapy on the treatment landscape of NSCLC, patients with wild-type NSCLC who experience disease progression following immunotherapy continue to face limited treatment options, with docetaxel-based standard-of-care therapy offering only modest efficacy.

In recent years, emerging approaches such as immunotherapy-based combinations and ADCs have brought new hope. However, multiple large-scale Phase III clinical trials in NSCLC patients who had failed both platinum-based chemotherapy and immunotherapy have not yet delivered satisfactory outcomes. Therefore, there remains a substantial and urgent unmet medical need in the post-immunotherapy setting for NSCLC.

As a PD-1/IL-2α-bias bispecific molecule, IBI363 has demonstrated encouraging clinical benefit in immunotherapy-resistant NSCLC, with both objective response rate (ORR) and progression-free survival (PFS) showing meaningful improvement. Notably, in the 3 mg/kg Q3W cohort, more than 40% of patients with either squamous or adenocarcinoma histology survived beyond 24 months. These findings highlight the potential of IBI363 to generate a durable immunotherapy tail effect and deliver long-term survival benefits for patients."

Dr. Hui Zhou, Chief R&D Officer (Oncology Pipeline) of Innovent, stated: "While immunotherapy has significantly improved survival outcomes for certain patients, treatment options remain extremely limited for patients with NSCLC who do not respond to immunotherapy and lack actionable driver gene mutations, making long-term survival difficult to achieve.The proof-of-concept (PoC) data presented at this year’s ASCO (Free ASCO Whitepaper) meeting are highly encouraging. IBI363 has demonstrated not only meaningful short-term disease control, but also, through extended follow-up, validated the unique long-term survival benefits of its dual mechanism of action, combining immune checkpoint blockade with cytokine agonism. We are excited about the potential of IBI363 to provide a novel treatment option for a broad population of patients and ultimately help deliver durable, 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 not only blocks PD-1 but also selectively delivers IL-2 to the tumor through binding to IL-2 receptor alpha.

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 31, 2026, View Source;innovent-presents-long-term-follow-up-results-from-the-poc-study-of-ibi363-tak-928-pd-1il-2-bias-bispecific-fusion-protein-showing-robust-survival-benefits-in-advanced-immunotherapy-resistant-non-small-cell-lung-302786450.html [SID1234666265])

On May 31, 2026 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, reported updated results from its Phase 1/2 trial evaluating brenetafusp in patients with heavily pretreated advanced melanoma. The data is presented in a poster at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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"I am pleased to present these updated brenetafusp data at ASCO (Free ASCO Whitepaper). Patients with advanced melanoma who progress on anti-PD-1 therapy have limited options, and seeing meaningful disease control in heavily pretreated patients is genuinely promising. These results support continued evaluation of brenetafusp in advanced melanoma," said Professor Georgina Long, Medical Director, Melanoma Institute Australia, The University of Sydney.

"These data with brenetafusp in heavily pretreated advanced melanoma show consistent responses and survival even in those with poor prognosis, including patients with primary PD-1 resistance," said Mohammed Dar, Chief Medical Officer of Immunocore. "These data also reinforce our confidence in the potential of brenetafusp at the dose of 160 mcg in combination with nivolumab in first-line advanced melanoma, in the ongoing Phase 3 PRISM-MEL-301 trial."

Phase 1/2 efficacy data

In the 66 patients treated with brenetafusp monotherapy (target doses 20-320 mcg), the median overall survival (OS) was 14.3 months (95% CI: 11.3-20.4; median follow up of 22.4 months) with a landmark OS rate of 87% at 6 months and 57% at 12 months. The disease control rate (DCR = partial responses and stable diseases) was 52%, while the overall response rate (ORR) was 12%.

Multiple measures of clinical benefit (6-month OS, DCR, ORR, tumor reduction) were numerically higher for patients treated with the 160 mcg dose – despite worse baseline prognostic factors compared to those treated with 40 mcg. These data support selection of 160 mcg for the ongoing Phase 3 trial evaluating brenetafusp + nivolumab vs. standard nivolumab regimens (NCT06112314) in first-line advanced melanoma. The safety profile was similar at both doses.

Median OS was 14.7 months for patients with primary PD-1 resistance, defined as progression within 6 months of starting the first regimen containing anti-PD1. Despite these patients having primary PD-1 resistance, the median OS was similar to all monotherapy patients (14.3 months).

In exploratory analyses, circulating tumor DNA (ctDNA) response in patients with PD-1 primary resistance was numerically higher (53%; 8/15) compared to the overall group (38%; 19/50). Treatment outcome was not impacted by PD-L1 status and was shown, in this exploratory analysis, to be associated with tumor expression of beta 2 microglobulin – a protein involved in antigen presentation – and baseline peripheral blood T cell fitness, which has been shown to be better in earlier lines of therapy.

In the 10 patients treated with brenetafusp in combination with pembrolizumab, the data showed numerically higher ORR and DCR compared to monotherapy, with efficacy also reported in patients with PD-1 primary resistance.

Phase 1/2 safety data

Brenetafusp was generally well tolerated, showing a predictable, mechanism-driven safety profile as monotherapy and in combination. The most common treatment-related adverse events (TRAEs) (≥20%) – which were reversible and attenuated over time – included CRS (56%; predominantly low grade, reversible, and attenuated over time), rash (44%), pyrexia (44%), chills (38%), fatigue (31%), decreased lymphocyte count (38%), nausea (25%), and pruritus (44%). The most frequent Grade 3-4 TRAE was transient decreased lymphocyte count (25%). There were three TRAEs that led to treatment discontinuation (two monotherapy patients and one combination patient).

Phase 1/2 trial overview

The Phase 1/2 trial (NCT04262466; EudraCT 2019-004046-16) enrolled patients with unresectable or metastatic melanoma who were HLA-A*02:01-positive (central testing) and previously treated with anti-PD-(L)1 therapy. Brenetafusp was administered as a weekly IV infusion with step dosing to a target dose. Tumor response was assessed by RECIST every 9 weeks; ctDNA was assessed every three weeks.

Second poster: Effect of IL7 on T cell fitness and ImmTAC anti-tumor activity

In a second poster presented during ASCO (Free ASCO Whitepaper) 2026, the Company built on previously disclosed data regarding the importance of T cell fitness for the efficacy of ImmTAC molecules. The new data demonstrated the anti-tumor activity of these therapies may increase when combined with IL7 in vitro. This study showed that IL7 treatment expanded naïve/stem-like memory T cells, enhanced ImmTAC-mediated T cell induction of IFNγ secretion and tumor killing, as well as reduced immune checkpoint receptor expression and T cell exhaustion. Additionally, a single dose of IL7 resulted in a sustained increase in T cell fitness of cancer patients. Taken together, the in vitro and in vivo data are consistent with the hypothesis that a combination with IL7 may increase the anti-tumor activity of ImmTAC therapies.

Presentations details (ASCO 2026)

Title: Phase 1 evaluation of the PRAME-targeted ImmTAC brenetafusp in advanced melanoma (Mel). (Abstract number: 9527)
Session: Melanoma/Skin Cancers (Poster Board: 243)
Date and Time: May 31, 2026, 9:00 AM-12:00 PM CDT

Title: Effect of IL7 on ImmTAC-mediated killing by T cells in vitro and T cell fitness in patients (Abstract number: 2662)
Session: Developmental Therapeutics – Immunotherapy (Poster Board: 452)
Date and Time: May 30, 2026, 1:30 PM-4:30 PM CDT

(Press release, Immunocore, MAY 31, 2026, View Source [SID1234666248])