ASCO: Innovent, Takeda's PD-1/IL-2 bispecific shows 86.4% response rate in early trial for NSCLC

Innovent Biologics (HKEX: 01801), the Suzhou-based biopharmaceutical company, [reported preliminary proof-of-concept data](https://www.prnewswire.com/news-releases/2026-asco-abstract-highlights--innovent-announces-preliminary-poc-data-of-ibi363-pd-1il-2-bias-bispecific-fusion-protein-in-combination-with-chemotherapy-as-first-line-treatment-for-advanced-nsclc-showing-encouraging-efficac-302779649.html) from the IBI363 NSCLC trial at the 2026 American Society of Clinical Oncology Annual Meeting, with the Phase Ib combination study showing an 86.4% objective response rate in PD-L1 negative or low-expressing patients treated with the optimized 3→1.5 mg/kg dosing regimen — a population historically underserved by current checkpoint inhibitor-based regimens. The Innovent Biologics clinical data, presented as an ASCO 2026 abstract, represent the first disclosed efficacy readout for IBI363 in the first-line advanced NSCLC treatment setting and provide early validation of a dose-titration strategy designed to balance immune activation with tolerability. The [Phase Ib study (NCT06468098)](https://app.allsci.com/clinical-trial/ASC-CT-0000000095611-1.0-1745770020) enrolled 80 patients with previously untreated locally advanced or metastatic NSCLC lacking sensitizing EGFR, ALK, or ROS1 alterations, with a data cutoff of December 22, 2025 and a median follow-up of 5.8 months. The dose optimization phase evaluated three IBI363 regimens in combination with platinum-based chemotherapy in patients with PD-L1 expression below 50%. The optimized step-down 3→1.5 mg/kg regimen produced the strongest efficacy signal, achieving a confirmed ORR of 81.8% and a disease control rate of 100% in 22 patients, with responses observed across both squamous and non-squamous NSCLC subtypes. By comparison, the flat 1.5 mg/kg and 3 mg/kg regimens generated lower confirmed ORRs of 42.1% and 57.1%, respectively, supporting the company’s rationale that an initial higher-dose immune activation phase followed by lower maintenance dosing may improve the balance between efficacy and tolerability. The [study](https://clinicaltrials.gov/study/NCT06468098) is an open-label, multicenter Phase Ib trial with a planned enrollment of 556 patients across advanced malignancies. The NSCLC cohort reported here represents a subset of 80 patients from the dose optimization stage, and the median follow-up of under six months limits conclusions about durability, progression-free survival, or overall survival. No randomized control arm was included in this stage of the trial, and the patient numbers within individual dose cohorts are small, constraining the precision of the response estimates. Innovent noted that the second stage of the proof-of-concept program — a randomized head-to-head comparison of the 3→1.5 mg/kg IBI363 plus chemotherapy regimen versus pembrolizumab plus chemotherapy across all PD-L1 expression levels — is currently ongoing. That stage will provide the first controlled efficacy comparison for IBI363 in this setting. IBI363 is a PD-1/IL-2 bispecific immunotherapy designed to enhance anti-tumor T-cell activity while limiting the systemic toxicity historically associated with IL-2 therapies. The rationale for the step-down dosing schedule draws on the observation that immunotherapy-naive tumors exhibit lower baseline immunosuppression, allowing an initial higher IL-2 activation pulse followed by a lower maintenance dose to sustain the immune-sensitive microenvironment. The immunotherapy chemotherapy combination strategy is designed to leverage chemotherapy-induced antigen release to prime the immune response during cycle one. The clinical context for these data centers on the limited benefit that PD-1 inhibitor-based regimens have historically provided in PD-L1 low or negative NSCLC. In the KEYNOTE-407 trial of pembrolizumab plus chemotherapy in first-line squamous NSCLC, ORRs were 67.4% and 54.5% in the PD-L1 1–49% and PD-L1 negative subgroups, respectively. In KEYNOTE-189, covering non-squamous disease, the corresponding figures were 50.0% and 33.1%. The ORR of 86.4% observed in the 3→1.5 mg/kg IBI363 cohort — drawn from a PD-L1 negative or low population — is numerically higher than these historical benchmarks, though cross-trial comparisons are limited by differences in study design, duration, patient selection, and the absence of a concurrent control arm in the IBI363 data. The squamous-enriched composition of the IBI363 cohort (66.3% squamous) also complicates direct comparison with non-squamous-predominant historical datasets. IBI363 has received two Fast Track Designations from the US FDA and[ three Breakthrough Therapy Designations ](https://app.allsci.com/news/ASC-NR-0000002353877-1.0-1778457961?query=IBI363)from China's National Medical Products Administration. In October 2025, Innovent entered a [license and collaboration agreement with Takeda](https://app.allsci.com/news/ASC-NR-0000000555424-1.0-1774444636?query=IBI363), under which the two companies will co-develop IBI363 globally and co-commercialize it in the US, with Takeda holding exclusive commercialization rights outside the US and greater China. The asset carries the Takeda development code TAK-928. Beyond NSCLC, IBI363 is being evaluated in a pivotal Phase II study in acral and mucosal melanoma and a global Phase III trial in immunotherapy-resistant squamous NSCLC, alongside multiple Phase Ib/II studies in colorectal cancer and other solid tumors. The ongoing randomized stage of the first-line NSCLC proof-of-concept program will be the next material data inflection point for the asset in this indication. *** This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: [https://allsci.com/news/](https://allsci.com/news/) --- Spot something wrong? [Report an issue with this article](https://newsgen-prod.reframedata.com/feedback/ibi363-lung-cancer-trial-innovent-biologics-shows)