Innovent presents first clinical data for first-in-class EGFR/B7H3 bispecific ADC

Overview

Updated 1 hour ago

Innovent Biologics presented the first clinical data for IBI3001, the first EGFR/B7H3 bispecific antibody-drug conjugate to reach patients, at the 2026 European Society for Medical Oncology (ESMO) congress in a Proffered Paper session. Across 53 evaluable patients with advanced solid tumors, 78.9% of whom had received two or more prior treatment lines, IBI3001 produced a 30.2% objective response rate and an 88.7% disease control rate.

IBI3001 pairs two cancer targets on one molecule: EGFR, a classic driver of tumor growth, and B7H3, a protein enriched across many solid tumors. The design mirrors what has worked in other topoisomerase-inhibitor ADCs—a drug-to-antibody ratio of 4 and a potent bystander effect that kills neighboring tumor cells. The strongest signals appeared in small-cell lung cancer, where 8 patients produced a 62.5% response rate, and EGFR-mutant non-small-cell lung cancer, where median progression-free survival reached 7.7 months.

The readout is early, and each subgroup is small. Grade 3 or higher treatment-related adverse events affected 47.4% of patients, mostly hematologic toxicities, with no treatment-related deaths. Innovent has moved IBI3001 into a Phase 1b dose-optimization study and plans expansion in later-line refractory cancers.

Why it matters

If the signals hold, one bispecific ADC could extend treatment options for EGFR-mutant lung, pancreatic, and small-cell lung cancers.

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Key Indicators

30.2%

Objective response rate across all 53 evaluable patients

Across tumor types; 78.9% of enrolled patients had received two or more prior treatments.

45.0%

Response rate at the 8 mg/kg dose

Best-efficacy dose cohort; disease control rate reached 100%.

7.7 months

Median progression-free survival in EGFR-mutant NSCLC

16 patients; disease control rate was 93.8%.

62.5%

Response rate in small-cell lung cancer

5 of 8 evaluable SCLC patients responded; disease control rate reached 100%.

47.4%

Grade 3 or higher treatment-related adverse events

Hematologic toxicities dominated; one patient discontinued, no treatment-related deaths.

Voices

Curated perspectives — historical figures and your fellow readers.

Ever wondered what historical figures would say about today's headlines?

People Involved

Hui Zhou

Chief R&D Officer (Oncology), Innovent Biologics

Leading IBI3001 development and the company's AD C pipeline

Organizations Involved

Innovent Biologics

Biopharmaceutical company (HKEX: 01801)

Developer of IBI3001

Suzhou-based company developing oncology, autoimmune, metabolic, and ophthalmic drugs with a growing ADC franchise.

European Society for Medical Oncology (ESMO)

Professional medical society

Host of the 2026 congress where the data was presented

ESMO is Europe's main professional society for medical oncology; its annual congress is one of the world's largest oncology meetings.

Timeline

April 2024 October 2026

4 events Latest: Today

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October 2026
First IBI3001 Phase 1 data presented at ESMO
Today Clinical data release

At ESMO 2026, Innovent presents IBI3001 Phase 1 data in a Proffered Paper session and publishes full results via press release.
Today
September 2026
Innovent announces ESMO presentation lineup
Announcement

Innovent says it will unveil global multicenter Phase 1 data for IBI3001 at the 2026 ESMO congress.
September 23rd, 2026
March 2026
Data cutoff for Phase 1a analysis
Data milestone

The Phase 1a analysis locks at 57 enrolled patients (40 in China, 17 in Australia) with a median follow-up of 6.4 months.
March 31st, 2026
April 2024
Innovent initiates Phase 1 study of IBI3001
Clinical trial

Innovent opens a Phase 1 study (NCT06349408) of IBI3001 in patients with solid tumors, originally planned in Australia for up to 180 participants.
April 2024

Scenarios

IBI3001 enters registrational trials in EGFR-mutant NSCLC

Likely Resolves by End of 2028

Discussed by: Innovent's own statements; the company named EGFR-mutant NSCLC and other refractory cancers as Phase 1b expansion priorities.

EGFR-mutant NSCLC produced the most mature signal: 31.3% ORR, 93.8% disease control, and 7.7-month median PFS in 16 patients who had progressed on prior therapy. Patients who develop resistance to osimertinib have few options beyond chemotherapy. If Phase 1b dose optimization confirms the response, Innovent could open a registrational study in this population.

Phase 1b finds the therapeutic window too narrow

Possible Resolves by Q2 2028

Discussed by: VCBeat's analysis of the ESMO data; the 47.4% grade 3+ TRAE rate, dominated by hematologic toxicity, is the main constraint on dose escalation.

The 8 mg/kg cohort delivered the best efficacy (45% ORR) but also produced a dose-limiting toxicity, and the 10 mg/kg cohort saw another. If dose optimization lands below 6 mg/kg to improve tolerability, response rates could slip below Phase 1a levels. The open question is whether the window between effective and toxic dosing is wide enough for a commercially viable drug.

Pancreatic cancer becomes a lead expansion indication

Possible Resolves by End of 2028

Discussed by: The ESMO dataset; pancreatic cancer lacks standard options beyond third line, making the 6.9-month median PFS noteworthy.

Pancreatic cancer is notoriously difficult to treat, and patients in later lines typically have short survival. A 6.9-month median PFS in 15 patients, 86.7% of whom were beyond third line and 93.3% of whom had prior irinotecan, stands out. If the Phase 1b expansion duplicates this in a larger cohort, Innovent could prioritize pancreatic alongside EGFR-mutant NSCLC.

Historical Context

2 moments from history that rhyme with this story — and how they unfolded.

2016-2019

Trastuzumab deruxtecan Phase 1 (2016)

Daiichi Sankyo unveiled its HER2-targeted antibody-drug conjugate, trastuzumab deruxtecan (Enhertu), at a 2016 cancer conference. Built on a topoisomerase I inhibitor payload with bystander killing, it produced durable responses in breast cancer patients who had failed T-DM1. The FDA granted accelerated approval in December 2019.

Then

The drug became a standard therapy across HER2+ breast cancer and later expanded into gastric, lung, and colorectal cancers.

Now

It became the design blueprint for next-generation ADCs, proving that optimized payloads and bystander effects matter as much as the antibody.

Why this matters now

IBI3001 uses exatecan, a topoisomerase I inhibitor in the same chemical class as Enhertu's payload, and designs in bystander killing. Investors and oncologists will measure it against Enhertu's trajectory from Phase 1 to approval.

May 2021

Amivantamab approval for EGFR-mutant NSCLC (2021)

Janssen's amivantamab (Rybrevant), a bispecific antibody targeting EGFR and MET, was approved by the FDA for non-small-cell lung cancer with EGFR exon 20 insertion mutations. It was among the first bispecific antibody therapies cleared for a solid tumor.

Then

Showed that bispecific antibodies can succeed in EGFR-driven solid tumors where single-target antibodies fell short.

Now

Paved the regulatory and clinical path for dual-targeting biologics in lung cancer, now including ADCs like IBI3001.

Why this matters now

IBI3001 applies the same dual-target logic to an ADC context—delivering a cytotoxic payload on top of EGFR blockade rather than relying on signaling inhibition alone.