On June 1, 2026 NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel therapies to treat cancer, and Simcere Zaiming Pharmaceutical Co., Ltd., (Simcere Zaiming) an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Ltd (HKEX: 2096), reported the presentation of positive Phase 1 dose escalation data for SIM0505 at the American Society for Clinical Oncology (ASCO 2026) in Chicago, IL (poster #246). SIM0505 is an investigational antibody drug conjugate (ADC) targeting Cadherin-6 (CDH6) with a proprietary topoisomerase 1 inhibitor (TOPOi) payload. NextCure plans to host a virtual KOL Event on Tuesday, June 2, 2026 (register here) to review these data.

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Platinum-resistant ovarian cancer (PROC) and uterine serous carcinoma (USC) represent two of the most challenging gynecologic malignancies. In PROC, once platinum resistance develops, response rates to available therapies drop to as low as 10–25%, with a median overall survival of approximately 11 months. USC, while accounting for only 10% of uterine cancers, is responsible for about 40% of uterine cancer deaths, with 5-year survival falling to 33% in advanced-stage disease. Taken together, these two cancers represent a persistent and significant unmet need for more effective treatment options.1-3

The Phase 1 dose escalation study (NCT06792552) evaluated SIM0505 in 59 heavily pre-treated cancer patients, with a data cutoff of April 07, 2026. Patients in the U.S. (n=25) and China (n=34) received SIM0505 at doses ranging from 1.6 mg/kg to 9.6 mg/kg, regardless of CDH6 expression.

Positive efficacy data were observed, with an objective response rate (ORR) of:

● 55% (11/20) for gynecologic cancers (ovarian cancer and USC)
● 52.9% (9/17) for ovarian cancer
● 66.7% (2/3) for USC
● Responses were observed across a range of CDH6 expression
ORRs, above, are reported for patients within therapeutic dose cohorts of 4.8 – 8.0 mg/kg who had a minimum 12 weeks of follow-up at the data cut-off, and were determined by best response according to RECIST 1.1 criteria. Of the nine (9) ovarian patients with partial response (PR), there was one unconfirmed PR and one PR pending confirmation at next follow-up scan.

"Positive Phase 1 data presented at ASCO (Free ASCO Whitepaper) 2026 validate our conviction in SIM0505 as a potential best-in-class CDH6-directed therapy for gynecologic cancers. Meaningful response rates at 12 weeks, alongside a manageable safety profile, give us strong confidence in this program and reinforce our enthusiasm for the ongoing dose optimization study. We believe SIM0505 has broad potential in gynecologic cancers and beyond, and these data put us on a solid track toward pivotal studies and our goal of bringing this treatment to patients," said Michael Richman, President and CEO of NextCure.

"Data presented at ASCO (Free ASCO Whitepaper) 2026 underscore the promise of our ADC platform and SIM0505, purpose-designed to deliver better efficacy, safety and tolerability, combining a carefully selected EC1 CDH6 epitope with our proprietary CPT116 topoisomerase payload. These results validate the science behind the SIM0505 construct and the accelerating pace of the global development program. Together with our partner, we remain deeply committed to advancing innovative medicines for patients facing hard-to-treat cancers," said Renhong Tang, PhD, CEO of Simcere Zaiming.

"Treatment of gynecologic cancers has advanced meaningfully in recent years, yet the need for safer and more effective treatments remains real. CDH6 is an attractive target given its expression across ovarian, uterine, and other solid tumors. ADCs directed at this target have the potential to deliver the deeper, more durable responses these patients need. The early response rates observed for SIM0505 at ASCO (Free ASCO Whitepaper) 2026 are encouraging, and I believe the safety profile is manageable in routine clinical practice. I am enthusiastic about this program and its potential to advance the standard of care in gynecologic cancers," said Udayan Guha, MD, PhD, Chief Medical Officer of NextCure.

ASCO Poster Overview: "Phase 1, multicenter, first-in-human (FIH) global study of SIM0505, an anti-CDH6 (CDH6) antibody-drug-conjugate (ADC) in patients with advanced solid tumors"

Table 1: Study Subject Overview:

All Patients

Baseline Characteristics

(n=59)

Age, years: median (range)

58 (42-78)

Sex, %: Male/Female

3.4%/96.6%

Race, n (%)

Asian

34 (57.6%)

Black or African American

3 (5.1%)

White

20 (33.9%)

Other

2 (3.4%)

Tumor Type, n (%)

Ovarian

46 (78.0%)

USC/other endometrial

10 (16.9%)

Renal cell carcinoma (RCC)

3 (5.1%)

ECOG performance status, n (%)

0

16 (27.1%)

1

43 (72.9%)

Prior systemic anti-cancer regimen: median (range)

5 (1-12)

Table 2: Efficacy Overview:

Patient Group

ORR*

All gynecologic patients (n=20)

55% (11/20)

• Ovarian cancer (n=17)

52.9% (9/17)

• USC (n=3)

66.7% (2/3)

*Reported for patients within therapeutic SIM0505 dose cohorts of 4.8 – 8.0 mg/kg who had a minimum 12 weeks of follow-up at the April 7, 2026 data cut-off, and were determined by best response according to RECIST 1.1 criteria. Of the nine (9) ovarian patients with PR, there was one unconfirmed PR and one PR pending confirmation at next follow-up scan.

Overall safety: Favorable overall data, potentially manageable in routine practice setting (n=59):

● Grade 1 and 2 treatment emergent adverse events (TEAEs) predominantly hematological, nausea and vomiting
● Grade 3 and 4 TEAEs predominantly hematological and manageable without primary prophylaxis for hematological toxicities
● Treatment related adverse events (TRAEs) requiring dose discontinuation: n=3
A full copy of the poster will be available on the NextCure website under the Investor Relations "Events & Presentations" tab following the presentation.

Virtual KOL Event

NextCure will host a virtual KOL Event to discuss the ASCO (Free ASCO Whitepaper) 2026 data.

● Date: June 2, 2026
● Time: 8:00 AM ET
● Registration Link: Click here
A replay of the webinar will be accessible on the Events page of the NextCure website for 90 days.

About SIM0505

SIM0505 is a novel ADC directed to CDH6, featuring a proprietary TOPOi payload. The ADC is designed for broad anti-tumor activity, fast systemic clearance and an improved potential therapeutic window. SIM0505 is being evaluated in an open-label, Phase 1 study (NCT06792552) for the potential treatment of advanced solid tumors, including ovarian cancer, with an emphasis on PROC. The U.S. Food and Drug Administration granted Fast Track Designation to SIM0505 for the treatment of PROC. NextCure holds exclusive global rights for SIM0505, excluding China, Hong Kong, Macau, and Taiwan which are retained by Simcere Zaiming.

About the Phase 1 Trial of SIM0505

SIM0505 is being evaluated in a global Phase 1 open-label, multicenter study (NCT06792552) with sites in the U.S. and China. The Phase 1 dose escalation segment has evaluated SIM0505, at dose levels from 1.6 mg/kg to 9.6 mg/kg, in heavily pre-treated cancer patients with solid tumors including gynecologic cancers and renal cell carcinoma. As of the April 7, 2026 data cutoff, 59 patients were enrolled without preselection for CDH6 expression. Follow-up is ongoing.

In May 2026, NextCure initiated a Phase 1 dose optimization segment in gynecologic cancers, initially focusing on patients with PROC. The global study is expected to enroll up to 120 patients, with initial doses of 5.6, 6.4 and 7.2 mg/kg, at sites in the U.S., Canada, the EU and China.

About Ovarian Cancer4-8

Ovarian cancer is the fifth leading cause of cancer-related death among women. It is characterized by vague, easily overlooked symptoms like bloating, pelvic pain, and frequent urination that often go undetected until late stage. Risk factors include age, family history, BRCA1/2 mutations, and hormone therapy use. The median age at diagnosis is 63, and the overall 5-year relative survival rate is 51.6% — though early-stage diagnosis carries a 5-year survival rate of 91.7%. As of 2022, an estimated 244,000 women were living with ovarian cancer in the United States.

About Uterine Serous Cancer2

Uterine serous carcinoma is a rare but highly aggressive subtype of endometrial cancer, accounting for approximately 10% of uterine cancers and about 40% of uterine cancer deaths. It typically arises in postmenopausal women, with abnormal or postmenopausal bleeding as the most common presenting symptom. Risk factors include advancing age, a history of breast cancer, tamoxifen use, and hereditary breast-ovarian cancer syndrome. More than half of patients present with stage III or IV disease at diagnosis, contributing to its disproportionate mortality burden.

(Press release, NextCure, JUN 1, 2026, View Source [SID1234666312])

On June 1, 2026 Servier reported promising new Phase 1 clinical data for Emi-Le, an investigational antibody drug conjugate (ADC) directed against B7-H4, during an oral session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2026 Annual Meeting in Chicago, Illinois.

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Emi-Le is an advanced engineered ADC that is directed against B7-H4, an immune checkpoint protein that is highly expressed in ACC along with several other cancers. As part of an ongoing Phase 1 trial, a dose escalation and backfill cohort enrolled adult patients with advanced or metastatic solid tumors (n=180), including those with ACC (n=48) defined by an aggressive clinicopathologic phenotype and/or molecular features consistent with poor prognosis.

"Emi-Le represents a novel, targeted therapeutic approach for patients who suffer from recurrent, advanced or metastatic ACC. The recent FDA Breakthrough Designation further validates the critical unmet need for a targeted systemic therapy to address the challenging effects of this disease for affected individuals," said Elly Barry, MD, Chief Medical Officer, Day One Biopharmaceuticals, now part of Servier Group. "These encouraging data at ASCO (Free ASCO Whitepaper) indicate strong promise to support a population distinctly in need of effective therapies and will help inform the pivotal Phase 2 study we will undertake in a larger set of participants."

The analysis presented at ASCO (Free ASCO Whitepaper) found:

Emi-Le was well-tolerated demonstrating a distinct and potentially differentiated emerging safety profile:
Most treatment-related adverse events (TRAEs) were transient laboratory-based and/or low-grade. The most common TRAEs were transient AST increase (56%) generally asymptomatic and reversible proteinuria (54%), predominantly low-grade fatigue (42%) and nausea (33%).
The only Grade 3 TRAEs in ≥10% of pts were transient AST increase (20%) and proteinuria (23%). No Grade 4 or 5 TRAEs reported.
TRAEs leading to treatment discontinuation occurred in 3.9% of patients and no treatment-related deaths were reported.
Promising signals of efficacy among 45 evaluable participants with ACC.
Objective response rate (ORR) was 35.6%, including one complete response.
Disease control rate was 82.2%.
Further, a post-hoc analysis was conducted in a more clearly defined aggressive ACC subtype reflecting clinical features used in practice by clinicians and pathologists, including solid histology or high-grade transformation. This analysis (n=32 evaluable participants) reported promising signals:
Consistent tumor shrinkage, with an ORR of 46.9%, DCR of 81.3% and median PFS of 7.8 months.
"These data provide important insights into the use of a targeted ADC for the difficult-to-treat rare cancer ACC, most notably demonstrating favorable tolerability and a potentially differentiated safety profile," said Glenn J. Hanna, M.D., study investigator and Director, Center for Cancer Therapeutic Innovation at Dana Farber Cancer Institute. "The encouraging anti-tumor activity observed to date supports continued investigation of this program, particularly given the poor prognosis for patients with ACC and the lack of approved or preferred systemic therapies in the advanced or metastatic setting. If confirmed in further studies, this profile could potentially represent a paradigm shift in treatment."

(Press release, Servier, JUN 1, 2026, View Source [SID1234666328])

On June 1, 2026 Qurient Co., Ltd. (KRX: 115180) reported that the first patient has been dosed in a Phase 2 clinical study evaluating mocaciclib (Q901) in combination with fulvestrant for treatment of hormone receptor-positive (HR+) breast cancer. The trial specifically targets patients who have stopped responding to prior treatments containing CDK4/6 inhibitors. Mocaciclib is a highly selective and potent covalent inhibitor of cyclin-dependent kinase 7 (CDK7), developed to address significant unmet medical needs in advanced solid tumors, including treatment-resistant breast cancer.

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The dosing of the first patient with CDK4/6 inhibitor-resistant HR+ breast cancer marks a significant milestone in development of mocaciclib as a new therapeutic option. While CDK4/6 inhibitors combined with endocrine therapy have proven highly effective for treatment of HR-positive, HER2-negative metastatic breast cancer, many patients eventually experience disease progression due to innate non-responsiveness or acquired resistance. Mocaciclib is being investigated as a targeted solution to overcome the refractory conditions through cell cycle control and transcriptional regulation of key refractory mechanisms, such as PTEN-PI3K/AKT pathway activation.

"Dosing the first HR-positive breast cancer patient with mocaciclib is an important step forward in our mission to provide new therapeutic options for patients who have exhausted standard-of-care treatments," said Kiyean Nam, Ph.D., Chief Executive Officer of Qurient. "Because of its unique mechanism of action in cell cycle control and transcriptional regulation, mocaciclib holds promise for patients whose tumors have developed bypass mechanisms to evade CDK4/6 inhibition. We are highly encouraged by our latest findings in CDK7 biology and look forward to translating this science into meaningful clinical outcomes."

Mechanism of Action Rationale in HR+ Breast Cancer

Mocaciclib (Q901) provides a novel therapeutic strategy for HR+ breast cancer by targeting CDK7, a dual-function kinase essential for both cell cycle progression and transcriptional regulation:

Master Regulation of the Cell Cycle (CAK Inhibition): CDK7 acts as the CDK-activating kinase (CAK), responsible for phosphorylating the T-loop of other key cell cycle kinases, including CDK1, CDK2, CDK4, and CDK6. In HR+ breast cancer, resistance to CDK4/6 inhibitors frequently occurs through the loss of retinoblastoma (RB) protein function or the over-activation of the Cyclin E-CDK2 axis. This allows cancer cells to bypass the CDK4/6 blockade and re-enter the S-phase of division. By potently inhibiting CDK7, mocaciclib suppresses the activation of CDK2 and other downstream kinases, effectively shutting down these alternative escape routes and halting tumor proliferation.
Targeted Transcriptional Repression: Beyond cell cycle control, CDK7 is a core component of the transcription factor II H (TFIIH) complex. Mocaciclib selectively disrupts the transcription of heavily relied-upon oncogenic transcription factors (such as MYC and E2F) and suppresses the expression of genes that are activated by the PTEN-PI3K/AKT pathway, effectively neutralizing another mechanism of CDK4/6 inhibitor resistance.
About Mocaciclib (Q901)

Mocaciclib (Q901) is an intravenously administered, highly selective covalent CDK7 inhibitor currently advancing through Phase 1/2 clinical trials (NCT05394103). In addition to its potential as a monotherapy in HR+ breast cancer and other advanced solid tumors, mocaciclib has demonstrated profound synergy in preclinical models when used in combination with Topoisomerase 1 inhibitor-based antibody-drug conjugates (TOP1i-ADCs) and immune checkpoint inhibitors.

(Press release, Qurient Therapeutics, JUN 1, 2026, View Source [SID1234666344])

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])