On October 30, 2022 Akeso, Biopharma (9926. HK) ("Akeso") reported the Phase Ib clinical results of Ivonescimab (PD-1/VEGF bi-specific, AK112) in combination with etoposide and carboplatin in first-line treatment of extensive-stage small-cell lung cancer(ES-SCLC), in an oral presentation at the IASLC 2022 Asia Conference on Lung Cancer (Press release, Akeso Biopharma, OCT 30, 2022, View Source [SID1234622597]).
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Preliminary data of AK112 combination with etoposide and carboplatin showed a favorable safety profile and promising anti-tumor efficacy as first-line treatment in patients with ES-SCLC and may be a promising treatment option. Compared to the data from marketed PD-L1 inhibitors in combination with chemotherapy, AK112 in combination with chemotherapy demonstrated superior antitumor efficacy and survival benefit.
As of June 1, 2022, all patients had received at least one dose of AK112. The median follow-up time was 7.2 months.
Median progression-free survival (PFS) was 6.9 months, with a 6-month PFS rate of 52.1%,
Objective remission rate (ORR) was 87.5%, and disease control rate (DCR) was 96.9%.
Overall survival (OS) data are not mature.
No new safety signal was observed.
Lung cancer is one of the most common cancers globally and in China, with up to two-thirds of SCLC patients having ES-SCLC at first diagnosis, and etoposide + platinum has been the standard of care for first-line treatment of ES-SCLC for more than 30 years. Two PD-L1 inhibitors have been approved in combination with chemotherapy to treat ES-SCLC, but the survival benefit for patients remains very limited.
Two Phase III trials of Ivonescimab for major lung cancer indications are currently being conducted efficiently, including Ivonescimab plus chemotherapy versus chemotherapy in EGFR mutated advanced non-squamous NSCLC that failed in prior EGFR-TKI therapy, and Ivonescimab monotherapy versus Pembrolizumab monotherapy as the first-line treatment for NSCLC patients with positive PD-L1 expression.
Related Studies:
Atelelizumab (PD-L1) in combination with carboplatin and etoposide, was approved for the first-line treatment of ES-SCLC (IMpower133) which had a median PFS of 5.2 months, a median OS of 12.3 months, and an ORR of 60.2%. [1] [2]
Dulvalizumab (PD-L1) in combination with etoposide and either carboplatin or cisplatin, was approved for the first-line treatment of ES-SCLC (CASPIAN) which had a median PFS of 5.1 months, an ORR of 68%, and a median OS of 13 months[3]