- After long-term follow-up, IBI363 monotherapy demonstrated strong overall survival (OS) with a long tail effect in IO-resistant squamous NSCLC and adenoNSCLC
- IBI363 has entered a global Phase 3 clinical study (MarsLight-11) for IO-resistant squamous NSCLC; pending regulatory communications, initiation of a global Phase 3 clinical study of IBI363 for IO-resistant non-squamous NSCLC is also planned.
- Innovent and Takeda are co-developing IBI363 (Takeda R&D code: TAK-928) globally.
SAN FRANCISCO and SUZHOU, China, June 1, 2026 /PRNewswire/ — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, today announces updated data from the Phase 1 PoC clinical study of its first-in-class PD-1/IL-2α-bias bispecific fusion protein IBI363 (Takeda R&D code: TAK-928) in the treatment of advanced immunotherapy(IO)-resistant non-small cell lung cancer (NSCLC) The detailed data was presented today at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting.
The updated data is from a PoC clinical study conducted in China to evaluate the safety and efficacy of IBI363 monotherapy in subjects with advanced NSCLC (ClinicalTrials.gov, NCT05460767). As of the follow-up cutoff date of November 20, 2025, a total of 136 subjects with NSCLC had received IBI363 monotherapy (2 μg/kg QW~4mg/kg once every 3 weeks, Q3W).
IBI363 Showed Robust Survival Benefits with a Long Tail Effect in IO-Resistant Squamous NSCLC
- All 67 squamous NSCLC patients had no known EGFR mutations. Among them, 28 patients received IBI363 at 1 mg/kg Q2W or 1.5 mg/kg Q3W, and 31 patients received IBI363 at 3 mg/kg Q3W. In the 3 mg/kg Q3W dose group, the median PFS reached 10.1 (95%CI 6.0, 14.0) months, and the median OS achieved 18.2 (95%CI 10.7, NE; maturity 48.4%) months, with a 24-month OS rate of 47.8% (95%CI 28.7, 64.7).
IBI363 Showed Potential for Long-Term Survival Benefits with a Long Tail Effect in IO-Resistant Wild-type AdenoNSCLC, Especially in Patients with a Smoking History
- Among the 58 patients with EGFR wild-type adenoNSCLC, 30 patients received IBI363 at 0.6 mg/kg Q2W or 1 mg/kg Q2W or 1.5 mg/kg Q3W, and 25 patients received IBI363 at 3 mg/kg Q3W. In the 3 mg/kg dose group, the median PFS reached 4.2 (95%CI 3.0, 7.0) months, and the median OS achieved 15.2 months (95%CI 9.6, NE; maturity 56.0%), with a 24-month OS rate of 42.7% (95%CI 23.1, 61.0).
- Smoking history may be an important influencing factor for efficacy in immuno-resistant adenoNSCLC. In adenoNSCLC subjects with a smoking history, better survival benefits were observed. The median OS for smokers across all dose groups (N=31) reached 23.4 (95%CI 11.3, NE, maturity 48.4%) months.
IBI363 Showed a Favorable Safety Profile in Long-Term Follow-up
- In the long-term follow-up of the overall population (n = 136), IBI363 demonstrated a favorable safety profile: treatment-emergent adverse events (TEAEs) of grade 3 or above occurred in 30.6% of patients treated with 1/1.5 mg/kg and 64.9% of patients treated with 3mg/kg.
- The most common adverse events among all patients were arthralgia (52.2%, 3.7% ≥grade 3), anemia (46.3%, 4.4% ≥grade 3), and rash (39.0%, 8.8% ≥grade 3), which were mostly controllable and manageable with mild-to-moderate AEs. No new safety signals were observed.
Professor Jianya Zhou, The First Affiliated Hospital, School of Medicine, Zhejiang University, commented: “Lung cancer remains the most commonly diagnosed and deadliest malignancy worldwide, representing a major public health challenge. Despite the transformative impact of immunotherapy on the treatment landscape of NSCLC, patients with wild-type NSCLC who experience disease progression following immunotherapy continue to face limited treatment options, with docetaxel-based standard-of-care therapy offering only modest efficacy.
In recent years, emerging approaches such as immunotherapy-based combinations and ADCs have brought new hope. However, multiple large-scale Phase III clinical trials in NSCLC patients who had failed both platinum-based chemotherapy and immunotherapy have not yet delivered satisfactory outcomes. Therefore, there remains a substantial and urgent unmet medical need in the post-immunotherapy setting for NSCLC.
As a PD-1/IL-2α-bias bispecific molecule, IBI363 has demonstrated encouraging clinical benefit in immunotherapy-resistant NSCLC, with both objective response rate (ORR) and progression-free survival (PFS) showing meaningful improvement. Notably, in the 3 mg/kg Q3W cohort, more than 40% of patients with either squamous or adenocarcinoma histology survived beyond 24 months. These findings highlight the potential of IBI363 to generate a durable immunotherapy tail effect and deliver long-term survival benefits for patients.“
Dr. Hui Zhou, Chief R&D Officer (Oncology Pipeline) of Innovent, stated: “While immunotherapy has significantly improved survival outcomes for certain patients, treatment options remain extremely limited for patients with NSCLC who do not respond to immunotherapy and lack actionable driver gene mutations, making long-term survival difficult to achieve.The proof-of-concept (PoC) data presented at this year’s ASCO meeting are highly encouraging. IBI363 has demonstrated not only meaningful short-term disease control, but also, through extended follow-up, validated the unique long-term survival benefits of its dual mechanism of action, combining immune checkpoint blockade with cytokine agonism. We are excited about the potential of IBI363 to provide a novel treatment option for a broad population of patients and ultimately help deliver durable, long-term survival benefits.”
About IBI363 (PD-1/IL-2α-bias Bispecific Fusion Protein)
IBI363 is a first-in-class PD-1/IL-2α-bias bispecific fusion protein developed by Innovent Biologics. It functions by both blocking the PD-1/PD-L1 pathway and selectively activating the IL-2 pathway. The IL-2 arm of IBI363 is designed to maintain its affinity for IL-2Rα while reducing binding to IL-2Rβ and IL-2Rγ, thereby minimizing toxicity. The PD-1 binding arm not only blocks PD-1 but also selectively delivers IL-2 to the tumor through binding to IL-2 receptor alpha.
IBI363 is being evaluated in a series of clinical trials globally, led by a pivotal Phase II study in China in previously untreated acral and mucosal melanoma and a global multi-regional Phase III trial in immunotherapy-resistant squamous NSCLC. In parallel, multiple Phase Ib/II trials are evaluating IBI363 in NSCLC and CRC including the first-line and later line settings, and in additional tumor types. IBI363 has received two Fast Track Designations (FTD) from the U.S. FDA and three Breakthrough Therapy Designations (BTD) from China NMPA so far.
In October 2025, Innovent entered into a license and collaboration agreement with Takeda, under which Innovent and Takeda will co-develop IBI363 (Takeda R&D code: TAK-928) globally and co-commercialize IBI363 in the U.S., and Takeda will exclusively commercialize IBI363 worldwide other than the U.S. and greater China.
About Innovent
Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 18 products in the market. It has 5 assets in Phase III or pivotal clinical trials and 14 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Roche, Takeda, Sanofi, Incyte, LG Chem and MD Anderson Cancer Center.
Guided by the motto, “Start with Integrity, Succeed through Action,” Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.
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