On May 31, 2026 Oricell Therapeutics, a clinical-stage biotech company pioneering cancer immunotherapy, reported that its lead asset, Ori-C101, a GPC3-targeted CAR-T therapy, achieved a 66.7% objective response rate (ORR) in patients with Late-line refractory hepatocellular carcinoma (HCC). The data, selected for an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, highlight a potential new benchmark for patients who have exhausted standard therapies.

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Hepatocellular carcinoma (HCC) remains a critical global health challenge, particularly in China, which accounts for more than one-third of the world’s over 800,000 annual deaths from the disease. While frontline treatments have evolved, options for patients failing second-line therapy are scarce, with historical ORRs typically below 13%.

Oricell’s registrational Phase Ib BEACON study challenges this status quo. As of April 3, 2026, among 18 efficacy-evaluable patients with advanced, heavily pretreated HCC:

Overall ORR reached 50%.
At the Recommended Phase 2 Dose (RP2D), ORR surged to 66.7%, with a disease control rate (DCR) nearing 90%.
Durability was profound: One patient achieved a complete response (CR) lasting 24 months.
Safety was manageable: No immune effector cell-associated neurotoxicity syndrome (ICANS) or off-tumor toxicity was observed, with cytokine release syndrome (CRS) contained within controllable grades.
Long-Term Validation: From 2021 ASCO (Free ASCO Whitepaper) Poster to Registrational Data

Notably, as early as 2021, Oricell’s investigator-initiated trial (IIT) data for Ori-C101 were selected for a poster presentation at ASCO (Free ASCO Whitepaper). At that time, a striking response was observed in a late-line HCC patient following a single infusion: the first efficacy assessment showed a partial response (PR), with target lesions shrinking by 96.1% (from 155.45 mm to 6 mm) and alpha-fetoprotein (AFP) levels plummeting by 99.1% (from >80,000 ng/mL to 742 ng/mL). The patient achieved an overall survival (OS) of nearly three years.

The now-unveiled registrational clinical data further validate the clinical value of Ori-C101, reinforcing the consistency and reproducibility of Oricell’s approach from early proof-of-concept to pivotal trials.

Technology Backbone: A "Three-in-One" Engine Addressing Solid Tumor Barriers

Ori-C101’s exceptional performance stems from Oricell’s proprietary technology platforms, systematically addressing major challenges in CAR-T therapy for solid tumors: antigen heterogeneity, immunosuppressive tumor microenvironment (TME), and manufacturing efficiency.

1. OriAb (AI-Powered Antibody Discovery Platform）
The OriAb platform features a massive library comprising up to 10¹¹ fully human scFv and nanobody sequences. Utilizing a live-cell-based high-throughput screening strategy, the platform specifically identifies native conformational antigens, including challenging targets such as GPCRs, thereby avoiding the false-positive risks associated with purified protein-based screening. Furthermore, AI-assisted algorithms have compressed the antibody discovery and screening cycle from a traditional 12 months to just 3 months, significantly enhancing both efficiency and quality. The resulting high-specificity, optimally affine GPC3 antibody sequence equips Ori-C101 with a robust safety profile, effectively minimizing the risk of off-tumor toxicity.

2. OriArmoring (Structure-Enhanced Cell Platform)
The OriArmoring platform incorporates customized "armoring" elements designed to modulate T cell metabolic pathways and signal transduction based on the specific tumor microenvironment (TME). This engineering strategy enriches young, stem-like memory T cell subsets (Tscm), significantly enhancing the in vivo persistence of Ori-C101. By remodeling the local immune microenvironment, the platform effectively reverses immunosuppression, converting "cold tumors" into "hot tumors," thereby promoting the infiltration and activation of effector T cells. This approach overcomes the dual bottlenecks of the immunosuppressive TME and T cell exhaustion in solid tumors, ensuring durable, long-term responses. Additionally, the platform integrates logic-gating strategies—including ‘OR’ gating to prevent antigen escape and ‘AND’ gating to improve targeting precision—which collectively optimize the therapeutic index of the product.

3. OriOnGo: Flexible Manufacturing Platform (Classic / Rapid / In Vivo)
Built on a "Quality by Design" (QbD) philosophy, this platform includes proprietary manufacturing technologies. The rapid manufacturing process reduces ex vivo culture time to just 3 days, significantly improving productivity and lowering cost of goods (COGS). It ensures final product cell viability consistently above 95%, and compresses the vein-to-vein time to within 15 days. Moreover, the platform’s in vivo CAR-T product design and process capabilities open broader future applications for CAR-T therapy. This integrated manufacturing approach enables scalable, cost-effective production while maintaining product quality and patient access.

Executive Outlook

"Securing a third ASCO (Free ASCO Whitepaper) oral presentation validates our integrated platform strategy," said Dr. Helen Yang, Co-Founder and CEO of Oricell. "We are accelerating the pivotal Phase II development to bring this therapy to market. We are also actively seeking global partnerships to expand the reach of our technology and deliver hope to patients worldwide."

(Press release, OriCell Therapeutics, MAY 31, 2026, View Source;oricells-gpc3-car-t-ori-c101-hits-66-7-orr-in-late-line-hcc-signaling-best-in-class-potential-302786638.html [SID1234666262])

On May 31, 2026 Bayer reproted primary results from the Phase II ARACOG (AFT-47) trial, a head-to-head randomized trial conducted by Alliance Foundation Trials LLC, showed that patients treated with NUBEQA (darolutamide; n=55) experienced significantly less decline in objective cognitive performance over 24 weeks compared with those treated with enzalutamide (n=56).

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NUBEQA is indicated in the U.S. for the treatment of adult patients with metastatic castration-sensitive prostate cancer (mCSPC) both with and without docetaxel, and for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC).1

The trial met its primary endpoint, with median cognitive change from baseline to 24 weeks in maximally changed cognitive domain (MCCD) measuring -15.8% (-38.8, -2.6) for NUBEQA compared to -36.1% (-59.3, -16.7) for enzalutamide (p=0.009) in patients with advanced prostate cancer.2 Individual cognitive domain scores increased with NUBEQA, while scores remained stable or showed mild decline with enzalutamide.2 Cognitive function was measured objectively across domains including executive function, working memory, visual memory and attention. The largest percentage change between NUBEQA and enzalutamide was observed in executive function and working memory. Executive function and working memory are primarily responsible for short term memory and management of tasks in the brain, such as following conversations, remembering directions or keeping track of information. Results were presented today as an oral abstract at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Abstract #5005; May 30, 2026. 4:24 – 4:36 PM CDT) in Chicago.

"When choosing treatment for advanced prostate cancer, physicians and patients increasingly consider not only survival and disease control, but also how treatment may affect the patient’s daily life, including cognitive function," said Alicia K. Morgans, MD, MPH, Medical Oncologist and Director of the Adult Survivorship Program at Dana-Farber Cancer Institute and Principal Investigator of the ARACOG trial. "Data such as these offer evidence that can help inform treatment discussions and support a more patient-focused approach to care."

"At Bayer, we are committed to supporting people living with prostate cancer by advancing innovative treatment options," said Dr. Frank Verholen, Global Medical & Evidence Lead for NUBEQA at Bayer. "Data have demonstrated that darolutamide does not have the same impact on the central nervous system as enzalutamide."

Secondary endpoints of ARACOG included comparison in rates of crossover, which was permitted at 12 or 24 weeks for significant pre-specified decline in cognitive testing or patient-reported outcome measures, or for central nervous system-associated adverse events, including falls.2 By 24 weeks, 32 patients in the NUBEQA arm and 33 patients in the enzalutamide arm were eligible for crossover.2 Of the 23 patients who crossed over, all had been randomized to enzalutamide and crossed over to NUBEQA, most commonly due to decline in objective (n=14) or subjective (n=11) cognitive testing.2 Patients qualified for cross-over based on worsening seen on objective or subjective cognitive tests. Longer-term follow-up of cognitive change and patient-reported outcome measure (PROM) analyses are ongoing.

Prostate cancer is the leading cancer diagnosis among men in the U.S.3 Around 313,780 men are diagnosed with prostate cancer each year in the U.S.3 By 2040, prostate cancer diagnoses are projected to increase to 2.9 million worldwide.4 For men with mCSPC, just over a third (~38%) will survive five years or more after diagnosis, and most progress to castration-resistant prostate cancer (CRPC), a condition with limited long-term survival. 5,6,7

About the ARACOG trial8

ARACOG (NCT04335682) is a U.S. prospective, randomized, open-label Phase II trial conducted by the Alliance for Clinical Trials in Oncology, evaluating objective and patient-reported cognitive and quality-of-life outcomes in patients with metastatic castration sensitive prostate cancer (mCSPC), metastatic castration-resistant prostate cancer (mCRPC) or non-metastatic castration-resistant prostate cancer (nmCRPC) treated with NUBEQA or enzalutamide.

Patients (N=111) were enrolled and randomized 1:1 to treatment with enzalutamide or NUBEQA. CANTAB, a validated computer-based platform evaluating five cognitive domains, was performed at baseline, 12, 24 and 48 weeks. The primary endpoint was the percent change in the maximally changed cognitive domain from baseline to 24 weeks and was compared between groups with the Wilcoxon rank sum statistic. Secondary endpoints included comparison of crossover rates. A study limitation was that crossover criteria included subjective outcomes in the context of an open-label trial. CANTAB is a research tool and not used for clinical diagnosis.

About NUBEQA (darolutamide)1

NUBEQA (darolutamide) is an androgen receptor inhibitor (ARi) with a distinct chemical structure that competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription.

NUBEQA was developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.

NUBEQA is an androgen receptor inhibitor indicated for the treatment of adult patients with:

Non-metastatic castration-resistant prostate cancer (nmCRPC)
Metastatic castration-sensitive prostate cancer (mCSPC)
Metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel
IMPORTANT SAFETY INFORMATION

Warnings & Precautions
Ischemic Heart Disease – Ischemic heart disease, including fatal cases, occurred in patients receiving NUBEQA.

In a pooled analysis of ARAMIS and ARANOTE, ischemic heart disease occurred in 3.4% of patients receiving NUBEQA and 2.2% receiving placebo, including Grade 3-4 events in 1.4% and 0.3%, respectively. Ischemic events led to death in 0.4% of patients receiving NUBEQA and 0.4% receiving placebo.

In ARASENS, ischemic heart disease occurred in 3.2% of patients receiving NUBEQA with docetaxel and 2% receiving placebo with docetaxel, including Grade 3-4 events in 1.3% and 1.1%, respectively. Ischemic events led to death in 0.3% of patients receiving NUBEQA with docetaxel and 0% receiving placebo with docetaxel.

Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue NUBEQA for Grade 3-4 ischemic heart disease.

Seizure – Seizure occurred in patients receiving NUBEQA.

In a pooled analysis of ARAMIS and ARANOTE, Grade 1-3 seizure occurred in 0.2% of patients receiving NUBEQA. Seizure occurred from 261 to 665 days after initiation of NUBEQA.

In ARASENS, seizure occurred in 0.8% of patients receiving NUBEQA with docetaxel, including two Grade 3 events. Seizure occurred from 38 to 1754 days after initiation of NUBEQA.

It is unknown whether anti-epileptic medications will prevent seizures with NUBEQA. Advise patients of the risk of developing a seizure while receiving NUBEQA and of engaging in any activity where sudden loss of consciousness could cause harm to themselves or others. Consider discontinuation of NUBEQA in patients who develop a seizure during treatment.

Embryo-Fetal Toxicity – The safety and efficacy of NUBEQA have not been established in females. NUBEQA can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment with NUBEQA and for 1 week after the last dose.

Adverse Reactions

In ARAMIS, serious adverse reactions occurred in 25% of patients receiving NUBEQA and in 20% of patients receiving placebo. Serious adverse reactions in ≥1% of patients who received NUBEQA included urinary retention, pneumonia, and hematuria. Fatal adverse reactions occurred in 3.9% of patients receiving NUBEQA and 3.2% of patients receiving placebo. Fatal adverse reactions that occurred in ≥2 patients who received NUBEQA included death (0.4%), cardiac failure (0.3%), cardiac arrest (0.2%), general physical health deterioration (0.2%), and pulmonary embolism (0.2%). The most common (>2% with a ≥2% increase compared to placebo) adverse reactions, including laboratory test abnormalities, were increased AST (23%), decreased neutrophil count (20%), fatigue (16%), increased bilirubin (16%), pain in extremity (6%), and rash (4%). Clinically relevant adverse reactions occurring in 2% or more of patients treated with NUBEQA included ischemic heart disease (4%) and heart failure (2.1%).

In ARANOTE, serious adverse reactions occurred in 24% of patients receiving NUBEQA. Serious adverse reactions in ≥1% of patients who received NUBEQA included pneumonia (2%), urinary tract infection (1.8%), musculoskeletal pain (1.6%), hemorrhage (1.6%), arrhythmias (1.3%), and spinal cord compression (1.1%). Fatal adverse reactions occurred in 4.7% of patients receiving NUBEQA and those that occurred in ≥2 patients included sepsis (1.1%), craniocerebral injury (0.4%), and myocardial infarction (0.4%). The most common (≥10% with a ≥2% increase compared to placebo) adverse reaction is urinary tract infection (12%). The most common laboratory test abnormalities (≥15% with a ≥5% increase over placebo) are increased AST (32%), increased ALT (28%), increased bilirubin (17%), and decreased neutrophil count (16%). Clinically relevant adverse reactions in <10% of patients who received NUBEQA included arrhythmia (8.8%), pneumonia (3.6%), and myocardial infarction (0.7%).

In ARASENS, serious adverse reactions occurred in 45% of patients receiving NUBEQA with docetaxel. Serious adverse reactions in ≥2% of patients who received NUBEQA with docetaxel included febrile neutropenia (6%), neutrophil count decreased (2.8%), musculoskeletal pain (2.6%) and pneumonia (2.6%). Fatal adverse reactions occurred in 4% of patients receiving NUBEQA with docetaxel. Fatal adverse reactions in ≥2 patients who received NUBEQA included COVID-19/COVID-19 pneumonia (0.8%), myocardial infarction (0.3%), and sudden death (0.3%). The most common (≥10% with a ≥2% increase over placebo with docetaxel) adverse reactions are constipation (23%), rash (20%), decreased appetite (19%), hemorrhage (18%), increased weight (18%), and hypertension (14%). The most common laboratory test abnormalities (≥30%) are anemia (72%), hyperglycemia (57%), decreased lymphocyte count (52%), decreased neutrophil count (49%), increased AST (40%), increased ALT (37%), and hypocalcemia (31%). Clinically relevant adverse reactions in <10% of patients who received NUBEQA with docetaxel included fractures (8%), ischemic heart disease (3.2%), seizures (0.6%), and drug-induced liver injury (0.3%).

Drug Interactions

Effect of Other Drugs on NUBEQA – Concomitant use of NUBEQA with a combined P-gp and strong or moderate CYP3A4 inducer decreases darolutamide exposure which may decrease NUBEQA activity. Avoid concomitant use of NUBEQA with combined P-gp and strong or moderate CYP3A4 inducers.

Concomitant use of NUBEQA with a combined P-gp and strong CYP3A4 inhibitor increases darolutamide exposure which may increase the risk of NUBEQA adverse reactions. Monitor patients more frequently for NUBEQA adverse reactions and modify NUBEQA dosage as needed.

Effects of NUBEQA on Other Drugs – NUBEQA is an inhibitor of BCRP transporter. Concomitant use of NUBEQA increases the AUC and Cmax of BCRP substrates, which may increase the risk of BCRP substrate-related toxicities. Avoid concomitant use with drugs that are BCRP substrates where possible. If used together, monitor patients more frequently for adverse reactions, and consider dose reduction of the BCRP substrate drug.

NUBEQA is an inhibitor of OATP1B1 and OATP1B3 transporters. Concomitant use of NUBEQA may increase the plasma concentrations of OATP1B1 or OATP1B3 substrates. Monitor patients more frequently for adverse reactions of these drugs and consider dose reduction while patients are taking NUBEQA.

Review the Prescribing Information of drugs that are BCRP, OATP1B1, and OATP1B3 substrates when used concomitantly with NUBEQA.

For important risk and use information about NUBEQA, please see the accompanying full Prescribing Information.

(Press release, Bayer, MAY 31, 2026, View Source [SID1234666278])

On May 31, 2026 CStone Pharmaceuticals ("CStone," HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of therapies for oncology, immunology, inflammation, and other key disease areas, reported that multiple key clinical updates for its core asset CS2009 (a PD-1/VEGF/CTLA-4 trispecific antibody) were presented in two posters at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, covering Phase I/II clinical data in first-line and later-line NSCLC and CRC patients, as well as mature Phase I data from longer follow-up in patients with advanced solid tumors.

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Dr. Jason Yang, CEO, President of R&D, and Executive Director at CStone, commented, "As the clinical evidence continues to mature, CS2009 has advanced beyond early mechanistic validation and preliminary efficacy exploration to deliver a compelling proof of concept (POC). We are encouraged by its consistently favorable safety profile, both as a monotherapy and in combination with chemotherapy, alongside broad antitumor activity across multiple treatment settings. CS2009 has demonstrated promising potential to address key challenges in cancer immunotherapy, including overcoming immunotherapy resistance and extending clinical benefit to tumor types that have historically shown limited responsiveness to immunotherapy. Robust antitumor activity has been observed across multiple cohorts, including both first-line and later-line NSCLC, as well as first-line and later-line pMMR/MSS mCRC. These data further validate the strength of CS2009’s triple-target synergistic mechanism and support its potential to serve as a next-generation immunotherapy backbone. Importantly, the findings provide a strong foundation for our planned global Phase III registrational MRCT and reinforce our confidence that CS2009 could ultimately offer transformative treatment options for patients with lung cancer, colorectal cancer, and a broad range of solid tumors."

Key Highlights of the Poster Presentations：

Non-Small Cell Lung Cancer (NSCLC)

In the ongoing Phase I/II study, CS2009 was evaluated as monotherapy or in combination with chemotherapy in advanced NSCLC patients without actionable oncogenic alterations. A total of 108 patients were enrolled across four groups:

(1) Group 1 (≥2L NSCLC monotherapy), n=57: CS2009 was dosed at 10–45 mg/kg, once every 3 weeks (Q3W);

(2) Group 2 (2/3L NSCLC combination therapy), n=9: CS2009 was dosed at 20 or 30 mg/kg, Q3W plus docetaxel;

(3) Group 3 (1L NSCLC monotherapy ), n=23: CS2009 was dosed at 20 or 30 mg/kg, Q3W;

(4) Group 4 (1L squamous NSCLC combination therapy), n=19: CS2009 was dosed at 20 or 30 mg/kg Q3W plus paclitaxel/carboplatin, followed by CS2009 maintenance therapy.

1. Baseline Patient Characteristics

In Group 1 (≥2L NSCLC monotherapy), 61.4% had received one prior line of therapy, 21.1% two lines, and 17.5% three or more lines. In Group 2 (2/3L NSCLC combination therapy), all patients had received one prior line of therapy.

2. Robust Efficacy*

(1) Group 3 (1L NSCLC monotherapy, PD-L1 high expression TPS ≥50%, n=16):

ORR was 81.3% (13/16) with a DCR of 100.0% (16/16); response rates were comparable in squamous (ORR: 87.5%, 7/8) and non-squamous (ORR: 75.0%, 6/8) histologies.

*Note: Efficacy analyses were performed only in patients who received at least one post‑baseline tumor assessment. The number of such patients is less than or equal to the total number of patients enrolled in the group.

(2) Group 4 (1L squamous NSCLC combination therapy, PD-L1 negative or low expression TPS ≤5%, n=8):

ORR was 75.0% (6/8) and DCR 100.0% (8/8); notably, the ORR in the PD-L1 TPS <1% subgroup reached 100.0% (4/4).
*Note: Efficacy analyses were performed only in patients who received at least one post‑baseline tumor assessment. The number of such patients is less than or equal to the total number of patients enrolled in the group.

(3) Group 1 (≥2L NSCLC monotherapy, most IO pretreated, n=54):

Across dose levels: Most patients showed sustained tumor shrinkage; median DOR was not reached, and the 6‑month DOR rate was 85.7%.
At 30 mg/kg: ORR was 24.0% (6/25) and DCR 60.0% (15/25); median DOR was not reached, with a 6‑month DOR rate of 80.0%. For patients who had received only prior immunotherapy plus platinum-doublet chemotherapy (n=13), ORR rose to 30.8% (4/13) and DCR to 84.6% (11/13).
(4) Group 2 (2/3L NSCLC combination therapy, n=6):

ORR was 66.7% (4/6), and DCR was 100% (6/6).
*Note: Efficacy analyses were performed only in patients who received at least one post‑baseline tumor assessment. The number of such patients is less than or equal to the total number of patients enrolled in the group.

3. Favorable Safety and Tolerability

(1) Group 1 (≥2L NSCLC monotherapy): The incidence of Grade ≥3 TRAE, irAE, and TRAE possibly related to anti-VEGF therapy were 19.3%, 12.3%, and 5.3%, respectively;

(2) Group 2 (2/3L NSCLC combination therapy): The incidence of Grade ≥3 TRAE was 44.4%, with no Grade ≥3 irAE or TRAE possibly related to anti-VEGF therapy observed;

(3) Group 3 (1L NSCLC monotherapy): The incidence of Grade ≥3 TRAE was only 4.3%, with no TRAE possibly related to anti-VEGF therapy observed;

(4) Group 4 (1L squamous NSCLC combination therapy): The incidence of Grade ≥3 TRAE and irAE were 26.3% and 10.5%, with no TRAE possibly related to anti-VEGF therapy observed.

Metastatic Colorectal Cancer (mCRC)

1. Later-line mCRC Monotherapy Cohort: 14 heavily pretreated patients with mCRC, mostly pMMR/MSS, received CS2009 30 mg/kg monotherapy. Among efficacy-evaluable patients (n=8), ORR was 25.0% (2/8) and DCR was 87.5% (7/8).

*Note: Efficacy analyses were performed only in patients who received at least one post‑baseline tumor assessment. The number of such patients is less than or equal to the total number of patients enrolled in the group.

2. 1L mCRC Combination Therapy Cohort: 14 treatment-naïve mCRC patients, mostly pMMR/MSS, received CS2009 30 mg/kg plus XELOX. Safety data showed Grade ≥3 TRAE in 14.3%, irAE in 7.1%, and TRAE possibly related to anti-VEGF in 14.3% (all grade 1–2, isolated events). In patients with at least one post-baseline tumor assessment (n=6), ORR reached 66.7% (4/6) and DCR was 100.0% (6/6).

*Note: Efficacy analyses were performed only in patients who received at least one post‑baseline tumor assessment. The number of such patients is less than or equal to the total number of patients enrolled in the group.

Phase I Dose Escalation in Advanced Solid Tumors: Safety, Efficacy, and PK/PD Characteristics

1. Baseline Patient Characteristics

A total of 118 heavily pretreated patients with advanced solid tumors were enrolled in the dose-escalation phase across six dose levels (1–45 mg/kg). Among them, 50.8% had prior immunotherapy and 45.8% prior anti‑angiogenic therapy.

2. Favorable Safety and Tolerability

(1) Dose escalation of CS2009 has been completed, with no Dose-Limiting Toxicities (DLTs) observed and Maximum Tolerated Dose (MTD) not reached;

(2) The incidence of Grade ≥3 TRAE, irAE, and TRAE possibly related to anti-VEGF therapy were 24.6%, 12.7%, and 5.1%, respectively. The incidence of infusion-related reactions was 4.2%, all grade 1-2 and manageable.

3. Overall Phase I Efficacy as Expected; Meaningful Signal in "cold tumors"

(1) In the overall efficacy-evaluable population (n=104), ORR was 17.3% (18/104) and DCR was 70.2% (73/104); median DOR was not reached, and the 6‑month DOR rate was 77.4%. At 20 mg/kg and 30 mg/kg, ORRs were 13.3% (4/30) and 22.7% (10/44), respectively, with DCRs around 70%.

(2) In addition to CRC, CS2009 monotherapy has also demonstrated encouraging antitumor activity in later-line ‘cold tumors’ that are insensitive to PD-(L)1, such as STS and nccRCC:

STS (n=12): ORR 33.3% (4/12), DCR 66.7% (8/12);
nccRCC (n=6): ORR 33.3% (2/6), DCR 100.0% (6/6).
4. Excellent PK/PD Characteristics

(1) CS2009 demonstrated linear PK with a half-life of 6-9 days, supporting Q3W dosing. No significant accumulation was observed at Cycle 3. The incidence of anti-drug antibody (ADA) positivity was extremely low at only 0.7% (1/139).

(2) PD profile demonstrated saturated receptor occupancy and robust T-cell activation/proliferation confirming PD-1/CTLA-4 blockade and deep and sustained VEGFA neutralization.

Receptor occupancy (RO) of PD-1/CTLA-4 on peripheral T cells reached saturation throughout the dosing interval at doses ≥20 mg/kg.
On cycle 1 day 8, CS2009 induced notable, dose-dependent upregulation of Ki67 (proliferation due to PD-1 and CTLA-4 blockade) and ICOS (activation due to CTLA-4 blockade) expression on both CD4+ and CD8+ T cells, collectively demonstrating effective PD-1 and CTLA-4 inhibition by CS2009.
Serum-free VEGFA reduced deeply and rapidly across all dose levels, and the effect sustained throughout dose intervals.
CStone will continue Phase II dose expansion in selected tumor types for dose optimization and to generate data as monotherapy or in combinations, supporting registrational trials in NSCLC, CRC and other indications. The first Phase III global MRCT is expected to be initiated by the end of 2026.

(Press release, CStone Pharmaceauticals, MAY 31, 2026, View Source;cstone-presents-updated-clinical-data-for-cs2009-pd-1vegfctla-4-trispecific-antibody-reinforcing-triple-target-synergy-and-delivering-strong-proof-of-concept-302786438.html [SID1234666263])

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])