On May 26, 2026 Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company") reported updated data from its Phase 1/2 clinical study (NCT06265727) of CRB-701 (SYS6002), a next-generation Nectin-4 targeted antibody drug conjugate (ADC). The new data demonstrate robust activity in the second line (2L) setting of two solid tumor types that express high levels of Nectin-4 and are primarily driven by human papilloma virus (HPV): oropharyngeal squamous cell carcinoma (OPSCC) and cervical cancer. These findings will be presented at the upcoming 2026 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held May 29 – June 2, 2026, in Chicago.
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The ongoing multi-center Phase 1/2 study is being conducted in the U.S. and Europe. The data reported today derives from an April 1, 2026 data cut of the Phase 1/2 study with a total safety population of 317 patients encompassing all tumor types and all doses. A total of 75 patients with HNSCC were enrolled at the 2.7 mg/kg and 3.6 mg/kg doses, of whom 71 were efficacy evaluable while 4 did not have post-baseline scans. A total of 72 patients with cervical cancer were enrolled at the 2.7 mg/kg and 3.6 mg/kg doses, of whom 70 were efficacy evaluable while 2 did not have post-baseline scans.
Safety (n=317)
CRB-701 continued to be safe and well tolerated, consistent with findings reported at the ESMO (Free ESMO Whitepaper) 2025 data cut. The most common treatment-related adverse events (TRAEs) occurring in more than 20% of participants were keratitis (49.2%), alopecia (25.6%), fatigue (22.4%), and dysgeusia (19.9%). Grade 3 adverse events (AEs) were reported in 19.2% of patients, and Grade 4 AEs were reported in 0.9% of patients. There were no Grade 5 events reported. The incidence of peripheral neuropathy remained low at 7.3%, with all events limited to Grade 1 or 2 severity. Skin-related AEs, excluding alopecia, were at 24%. There was only one Grade 3 event (0.3%) reported. There were no skin Grade 4 or 5 events, and no reported cases of Stevens-Johnson Syndrome (SJS) or toxic epidermal necrolysis (TEN). Overall, treatment discontinuations related to CRB-701 remained low at 2.8%. Ocular toxicities, a well-established side effect in multiple approved ADCs, continued to be manageable through prophylactic eye care interventions and dose reductions/interruptions. Ocular AEs were reported in 66.2% of participants, with the vast majority being transient in nature. Grade 3 events were reported in 12.6% of participants and only one Grade 4 event (0.3%) was reported involving exacerbation of pre-existing punctate keratitis and microcysts that resolved to baseline within six weeks. Discontinuations due to ocular AEs remained markedly low at 1.9%.
Efficacy in Patients with HNSCC Dosed with CRB-701 at 2.7 mg/kg or 3.6 mg/kg (total n=71)
OPSCC (n=41)
Dose 2.7 mg/kg (n=20) 3.6 mg/kg (n=21)
cORR* 20.0% (4/20) 42.9% (9/21)
DCR** 90.0% (18/20) 85.7% (18/21)
DoR (months) ongoing 4.8 6.3
PFS (months) ongoing 4.2 5.6
Non-Oropharyngeal HNSCC (n=30)
Dose 2.7 mg/kg (n=14) 3.6 mg/kg (n=16)
cORR* 7.1% (1/14) 0.0% (0/16)
DCR** 57.1% (8/14) 62.5% (10/16)
DoR (months) 4.4 NA
PFS (months) 2.3 2.7
HNSCC Biomarkers
HPV status was determined for 97.3% of the HNSCC participants in the 2.7 mg/kg and 3.6 mg/kg cohorts.
In line with published epidemiology, 57.3% of enrolled HNSCC patients were HPV+, with 85.4% of oropharyngeal patients being HPV+.
8 of the 9 patients who achieved PR in the OPSCC cohort were HPV+. In contrast, no confirmed PRs were observed in non-OPSCC HNSCC at the corresponding dose.
In-line with published literature, higher Nectin-4 levels were associated with HPV+ HNSCC.
In-depth biomarker analysis will be presented at a future conference.
*Confirmed objective response rate (cORR) calculated using patients’ confirmed best overall response (BOR) per RECISTv1.1**Disease control rate (DCR) calculated by summing numbers of response-evaluable patients who achieve a BOR of complete response (CR), partial response (PR) or stable disease (SD).
Efficacy in Patients with Cervical Cancer Dosed with CRB-701 at 2.7 mg/kg and 3.6 mg/kg
Cervical Cancer (n=70)
Dose 2.7 mg/kg (n=38) 3.6 mg/kg (n=32)
cORR* 18.4% (7/38) including 1 CR 34.4% (11/32) including 2 CRs
DCR** 55.3% (21/38) 75.0% (24/32)
DoR (months) ongoing 6.8 8.0
PFS (months) ongoing 2.8 4.3
*Confirmed objective response rate (cORR) calculated using patients’ confirmed best overall response (BOR) per RECISTv1.1**Disease control rate (DCR) calculated by summing numbers of response-evaluable patients who achieve a BOR of complete response (CR), partial response (PR) or stable disease (SD).
"These data provide important clarity on the clinical and commercial path for CRB-701 in 2L oropharyngeal and 2L cervical cancers, indications that are associated with HPV infection and high expression of Nectin-4, and for which approved and other investigational drugs have shown limited efficacy," said Yuval Cohen, Ph.D., Chief Executive Officer of Corbus. "In addition, these findings further validate our clinical development strategy aimed at targeting solid tumors outside of metastatic urothelial cancer. We look forward to advancing these programs into registrational trials starting with TEMPO-1, our upcoming OPSCC study initiating this summer."
"OPSCC, which now represents a growing majority of HNSCC cases treated in the U.S., continues to rise in incidence. Largely driven by HPV, OPSCC primarily affects men in their 50s and 60s with little or no history of smoking or heavy alcohol use. Approximately 40-50% of HNSCC patients that reach 2L have OPSCC with persistent, recurrent, or metastatic disease that remains incurable with current treatment options, representing a growing unmet need," said Glenn J. Hanna, M.D., Director of the Center for Cancer Therapeutic Innovation at Dana-Farber Cancer Institute. "A targeted therapy for this patient population—particularly one directed against the validated target Nectin-4—could represent a significant advance in care. I look forward to seeing how CRB-701 performs in a late-stage clinical study involving this underserved patient population."
Corbus is on track to initiate a registrational study of CRB-701 in 2L OPSCC ("TEMPO-1") in the summer of 2026. Broad alignment was reached with the U.S. Food and Drug Administration (FDA) on the trial design for a randomized controlled study (n=250), which will explore the efficacy and safety of CRB-701 compared to investigator’s choice of monotherapy with overall response rate (ORR) as the primary endpoint for potential accelerated approval and potential full approval based on overall survival (OS) benefit. Similarly, broad alignment was reached with the FDA regarding the trial design for a randomized controlled study of CRB-701 in 2L cervical cancer.
CRB-701 2026 ASCO (Free ASCO Whitepaper) Data Presentation Details
The oral presentation titled, "A phase 1/2 study of the next-generation Nectin-4-targeting antibody drug conjugate CRB-701 (SYS6002) in patients with recurrent or metastatic cervical cancer," will be presented by Professor Yohann Loriot, Gustave Roussy (Paris) on Friday, May 29 at 4:57 p.m. CDT (Abstract #5508).
The poster presentation titled, "A phase 1/2 study of the next-generation Nectin-4-targeting antibody drug conjugate CRB-701 (SYS6002) in patients with recurrent or metastatic head and neck squamous cell carcinoma," will be presented by Charlene Mantia, M.D., Dana-Farber Cancer Institute (Boston) on Saturday, May 30 at 4:30 p.m. CDT (Abstract #6062/Poster #519).
Pre-2026 ASCO (Free ASCO Whitepaper) Conference Call and Webcast Registration Details
Corbus will host a live conference call and webcast today, Tuesday, May 26, 2026, at 8:00 a.m. EDT to review the data. To register for the webcast: click here.
Investors Dial 1-877-704-4453
Int’l Investors Dial 1-201-389-0920
Conference ID 13760531
CallMe: click here
2026 ASCO (Free ASCO Whitepaper) HNSCC KOL Event
Corbus will host an in-person and virtual KOL event during ASCO (Free ASCO Whitepaper) 2026 to discuss CRB-701 development in OPSCC. The event will be held at Marriott Marquis Chicago starting at 6:30 a.m. CDT on Monday, June 1, 2026.
Date: Monday, June 1, 2026
Time: 6:30 a.m. CDT
Location: Marriott Marquis Chicago
Participants: Corbus Management Team, joined by leading HNSCC Experts:
Ari Rosenberg, M.D., University of Chicago
Glenn Hanna, M.D., Dana-Farber Cancer Institute
Cesar Augusto Perez Batista, M.D., Sarah Cannon Research Institute
A live question-and-answer session will follow the formal presentation. To register for the KOL event, click here. A replay of the event will also be available on the Corbus website.
About CRB-701
CRB-701 (SYS6002) is a next-generation antibody drug conjugate (ADC) targeting Nectin-4, that contains a site-specific, cleavable linker and a homogenous drug antibody ratio of 2, using MMAE as the payload. Nectin-4 is a clinically validated, tumor-associated antigen in urothelial cancer and highly expressed in other tumor types such as cervical and HNSCC. The FDA has granted two Fast Track designations to CRB-701 in HNSCC and cervical cancer.
(Press release, Corbus Pharmaceuticals, MAY 26, 2026, View Source [SID1234666049])