Innovent Delivers Oral Presentation on Phase 1 Clinical Data of IBI363 (First-in-class PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) in Advanced Non-small Cell Lung Cancer at the 2024 WCLC

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SAN FRANCISCO and SUZHOU, China, Sept. 11, 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.

Patients with at least 1
tumor assessment

sqNSCLC

1/1.5 mg/kg
(N=27)

3 mg/kg
(N=29)

3 mg/kg

with at least 12 weeks of follow-up
(N=18)

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<1% (n=22) and TPS≥1% (n=22) treated across the 1/1.5 mg/kg and 3 mg/kg doses, with ORRs of 36.4% and 31.8% respectively, suggesting IBI363 has efficacy regardless of PD-L1 expression.

  • IBI363 has a manageable safety profile. The most common treatment related adverse events (TRAEs) included arthralgia, anemia, hyperthyroidism, hypothyroidism and rash. Overall, 20.1% of patients experienced TRAEs ≥ grade 3 and 6.0% experienced TRAE leading to treatment discontinuation. In the 3 mg/kg Q3W subgroup (n=57), 17.5% experienced TRAEs ≥ grade 3 and 5.3% experienced TRAEs leading to treatment discontinuation. The safety profile was consistent with the overall population. No new safety signals were identified.

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