Glecirasib shows ‘impressive’ activity in certain patients with pancreatic cancer
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Key takeaways:
- About 42% of patients with pancreatic ductal adenocarcinoma achieved confirmed partial response.
- Treatment-related adverse events led to no deaths and caused zero patients to discontinue treatment.
Glecirasib exhibited antitumor activity among patients with pancreatic ductal adenocarcinoma and other solid tumors harboring the KRAS G12C mutation variant, study findings presented at ASCO Gastrointestinal Cancers Symposium showed.
“Glecirasib monotherapy has demonstrated promising clinical activity in previously treated patients with KRAS G12C-mutated [pancreatic ductal adenocarcinoma] and other tumor types,” Jian Li, PhD, MD, a member of the department of gastrointestinal oncology at Peking University Cancer Hospital and Institute, said during a presentation. “Glecirasib monotherapy is well tolerated, with a favorable safety profile.”
Background and methodology
The KRAS G12C mutation is an oncogenic driver and therapeutic target for solid tumors.
Glecirasib (Jacobio Pharmaceuticals) is a KRAS G12C inhibitor that has shown clinical activity among patients with non-small cell lung cancer and colorectal cancer.
Researchers conducted two phase 1/phase 2 trials evaluating the efficacy and safety of glecirasib in patients with solid tumors harboring KRAS G12C mutations — one trial exclusive to China and one for the U.S., Israel and the European Union.
Due to both trials having similar inclusion and exclusion criteria, researchers pooled the data from both studies to assess the effect of glecirasib monotherapy among various patient types with these solid tumors.
The analysis included 48 patients (86.5% Asian) in both trials who had previously received a median of one line of systemic therapy (range, 0-4).
The pooled data from both trials excluded patients with non-small cell lung cancer and colorectal cancer.
Saftey and tolerability served as the study’s primary endpoints, with secondary endpoints including efficacy measurements.
Results
Of the 47 patients evaluable for efficacy, 28 had pancreatic ductal adenocarcinoma and 19 had other solid tumors.
Among the 31 patients with pancreatic ductal adenocarcinoma, 13 (41.9%) achieved confirmed partial response; researchers also noted a disease control rate of 93.5% among such patients. Researchers observed a median OS of 10.7 months and median PFS of 5.6 months.
Among the 19 patients with other tumor types, researchers observed a confirmed objective response rate of 57.9% and a disease control rate of 84.2%.
Treatment-related adverse events of any grade occurred in 48 patients (92.3%); the most common included anemia (57.7%), blood bilirubin increase (50%), bilirubin conjugated increase (36.5%) and asthenia (23.1%).
Grade 3 or higher treatment-related adverse events occurred in 13 patients (25%), with no events being fatal or leading to treatment discontinuation.
Next steps
“The impressive clinical activities of glecirasib observed in [pancreatic ductal adenocarcinoma] and other tumor types warrant further expedited development,” Li said. “A pivotal clinical study in KRAS G12C mutated [pancreatic ductal adenocarcinoma] is currently enrolling in China.”
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Li, J, et al. Abstract 604. Presented at: ASCO Gastrointestinal Cancers Symposium; Jan. 18-20, 2024; San Francisco.
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