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

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

New Capabilities

Phase 1 readout shows tumor responses across heavily pre-treated solid tumors, including pancreatic and small-cell lung cancer

October 25th, 2026: First IBI3001 Phase 1 data presented at ESMO

Overview

Updated Oct 26

Innovent Biologics presented the first clinical data for IBI3001, an EGFR/B7H3 bispecific antibody-drug conjugate (ADC, a targeted drug carrying a chemotherapy payload), at the 2026 European Society for Medical Oncology (ESMO) congress. Of 57 patients who received the drug, 78.9% had two or more prior treatment lines. Among 53 patients evaluable for response, 30.2% responded and 88.7% had disease control.

The strongest signals came in small-cell lung cancer, where 5 of 8 patients responded, and in EGFR-mutant lung cancer, where median progression-free survival reached 7.7 months in 16 patients. Grade 3 or higher treatment-related side effects affected 47.4% of patients, mostly blood-related, with no treatment-related deaths. The sample sizes are small. 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.

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People Involved

HZ
Hui Zhou
Chief R&D Officer (Oncology), Innovent Biologics
Leading IBI3001 development and the company's AD C pipeline

Organizations Involved

Innovent Biologics
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)
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: October 25th, 2026 · 2 weeks ago
Tap a bar to jump to that date

  1. First IBI3001 Phase 1 data presented at ESMO

    Latest Clinical data release

    At ESMO 2026, Innovent presents IBI3001 Phase 1 data in a Proffered Paper session and publishes full results via press release.

  2. Innovent announces ESMO presentation lineup

    Announcement

    Innovent says it will unveil global multicenter Phase 1 data for IBI3001 at the 2026 ESMO congress.

  3. Data cutoff for Phase 1 analysis

    Data milestone

    The data cutoff for the Phase 1 analysis presented at ESMO. The press release reports 57 patients had received IBI3001 monotherapy by then.

  4. 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.

Scenarios

1

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 with EGFR-mutant NSCLC in the study. Options after EGFR-directed therapy are limited, but the source does not compare them. If Phase 1b dose optimization confirms the response, Innovent could open a registrational study in this population.

2

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.

3

Pancreatic cancer becomes a lead expansion indication

Possible Resolves by End of 2028

Discussed by: The ESMO dataset; The ESMO dataset. The 6.9-month median PFS is from 15 patients, 86.7% of whom were third line or later..

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 a topoisomerase I inhibitor payload and a bystander effect, as Enhertu does, 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.

Sources

(8)
+2
PR Newswire PRN Asia VCBeat Innovent Biologics Cnbio.xyz National Cancer Institute Drug Dictionary PR Newswire Innovent Biologics