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Association details:
Evidence:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

Akeso's Ivonescimab (PD-1/VEGF BsAbs) Granted Breakthrough Therapy Designation by China NMPA for the Treatment of Advanced NSCLC

Published date:
10/20/2022
Excerpt:
Akeso, Inc...announced that the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for Ivonescimab (PD-1/VEGF bispecific antibody) in combination with chemotherapy for treatment of advanced non-small cell lung cancer (NSCLC) patients with EGFR-mutated who failed to prior EGFR-TKI treatment....two Phase III trials of Ivonescimab for major lung cancer indications are ongoing. Receiving the Breakthrough Therapy Designation will accelerate the clinical development and product launch process of Ivonescimab...
Evidence Level:
Sensitive: C3 – Early Trials
Title:

AK112, a novel PD-1/VEGF bispecific antibody, in combination with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC): an open-label, multicenter, phase II trial

Published date:
08/18/2023
Excerpt:
AK112 plus platinum-doublet showed promising antitumor activity and safety not only in first-line treatment of advanced NSCLC patients without driver mutation but also in patients with EGFR-functional mutation who failed previous EGFR-TKI therapy and advanced NSCLC patients...
Secondary therapy:
carboplatin + pemetrexed
DOI:
10.1016/j.eclinm.2023.102106
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

A phase II study of AK112 (PD-1/VEGF bispecific) in combination with chemotherapy in patients with advanced non-small cell lung cancer

Published date:
05/26/2022
Excerpt:
...in cohort-1, among 26 evaluable pts with squamous cell carcinoma, 20 partial response and 6 stable disease were observed for a 76.9% ORR and a 100.0% DCR, median DOR and median PFS was not reached while 6-month PFS rate was 86.2%. In Cohort-2, among 19 evaluable pts, 13 partial response and 5 stable disease were observed for a 68.4% ORR and a 94.7% DCR while median DOR was 5.5 months, and median PFS was 8.3 months. AK112 plus chemotherapy has shown a promising anti-tumor efficacy in each cohort.
Secondary therapy:
pemetrexed; bisphosphonate bound paclitaxel; carboplatin
DOI:
10.1200/JCO.2022.40.16_suppl.9019
Trial ID: