SAN FRANCISCO and SUZHOU, China, Sept. 10, 2024 /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, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, announced the presentation of Phase 1 clinical data (ClinicalTrials.gov, NCT04085185) for IBI363 (first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein) in advanced non-small cell lung cancer at the 2024 World Conference on Lung Cancer (WCLC). Currently, Innovent is conducting Phase 1/2 clinical trials in China, U.S. and Australia to evaluate the safety, tolerability and efficacy of IBI363 in subjects with advanced solid tumors.
First-in-class PD-1/IL-2α-bias bispecific antibody IBI363 in patients with advanced non-small cell lung cancer in a Phase 1 study
This update on previously reported Phase 1 results focuses on the safety and efficacy of IBI363 in advanced non-small cell lung cancer (NSCLC). As of the follow-up data cutoff date of August 2, 2024, 134 patients were enrolled and received IBI363 monotherapy (up to 3 mg/kg Q3W), with 95.5% having received prior PD-(L)1 immunotherapy. The median duration of IBI363 exposure was 10 weeks, and 77.6% remained on treatment. In the group of 125 patients having at least one post-baseline tumor assessment, the overall ORR was 20.8% and DCR was 74.4%.
IBI363 demonstrated encouraging efficacy signals in IO-treated squamous NSCLC, with a trend toward relatively higher ORR and DCR in the 3 mg/kg Q3W group (n=29）compared to the 1/1.5 mg/kg Q2W/Q3W group (n=27) (see table below). Despite relatively short follow-up time for the 3mg/kg Q3W subgroup, among the 18 patients who had at least 12 weeks of follow-up or end of study, the ORR and DCR were 50% and 88.9%, respectively.
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Patients with at least 1 |
sqNSCLC |
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|
1/1.5 mg/kg |
3 mg/kg |
3 mg/kg with at least 12 weeks of follow-up |
|
|
Best overall response, n (%) |
|||
|
Partial Response (PR) |
6* |
10** |
9*** |
|
Stable Disease (SD) |
13 |
16 |
7 |
|
Progressive Disease (PD) |
8 |
2 |
2 |
|
Not Evaluable (NE) |
0 |
1 |
0 |
|
ORR, % (95% CI) |
22.2% (8.6, 42.3) |
34.5% (17.9, 54.3) |
50.0% (26.0, 74.0) |
|
DCR, % (95% CI) |
70.4% (49.8, 86.2) |
89.7% (72.6, 97.8) |
88.9% (65.3, 98.6) |
*6 patients had confirmed PR; **9 out 10 patients had confirmed PR; ***8 of 9 patients had confirmed PR.
As of the data cutoff date, for patients with squamous NSCLC who were treated with IBI363 at 1/1.5 mg/kg, the median follow up time was 7.5 months, and the median PFS was 5.5 months (95% CI, 1.5-8.3); currently, the 12-month PFS rate is 30.7%, showing a long-term benefit advantage of immunotherapy. The median PFS was not reached for subjects who received 3mg/kg Q3W.
Similar responses were observed among squamous NSCLC patients with PD-L1 TPS