Jacobio Pharmaceuticals’s pancreatic cancer candidate glecirasib has shown better safety and efficacy data than previous studies in a Phase I/II trial in patients with pancreatic cancer and other solid tumours.
The Phase I/II monotherapy global study of glecirasib showed a confirmed objective response rate (cORR) of 48% and a disease control rate (DCR) of 90%.
The study results will be used to submit a new drug application (NDA) for pancreatic cancer.
The non-randomised, open-label trial (NCT05002270) is investigating glecirasib as a treatment for patients with pancreatic cancer and advanced solid tumours harbouring KRAS G12C mutation. One KRAS [Kirsten rat sarcoma viral oncogene homolog] mutation is present in up to 25% of all human tumours.
The primary objective of the Phase I portion of the study was to evaluate the safety and tolerability of the monotherapy to determine the maximum tolerated dose while the Phase II portion evaluated the preliminary antitumor activity of glecirasib administered alone and in combination with cetuximab during dose expansion phase in adult participants with advanced solid tumours harbouring KRAS G12C mutation.
Jacobio said that the most recent safety and efficacy data is better than the published data of similar studies.
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The trial enrolled 52 patients with pancreatic cancer and other solid tumours harbouring KRAS G12C mutation in China, the US, Europe, Israel and other regions.
Of the 52 patients, 31 had pancreatic cancer and 21 patients had other solid tumours including eight with biliary tract tumours, three with gastric cancer, three with small bowel cancer, two with appendix cancer, and five with other solid tumours.
JAB-21000 inhibits KRAS (G12C) signalling and tumour cell growth. KRAS, a signalling protein acts as a molecular on/off switch. Its mutation leads to abnormal signalling in cancer cells. The drug candidate inhibits this mutant Ras to suppress cancer cell signalling. This results in suppression of cancer cell proliferation.
In August 2023, the candidate received breakthrough therapy designation as a treatment for pancreatic cancer patients with the KRAS G12C mutation.
Pancreatic cancer landscape
Pancreatic cancer is the 12th most common cancer worldwide. It is the 12th most common cancer in men and the 11th most common cancer in women.
According to a report by GlobalData, published in April 2022, there were five leading marketed drugs for the treatment of pancreatic cancer, with AstraZeneca’s Lynparza (olaparib) being a key player in the landscape. Last year, GlobalData predicted the drug’s global sales to hit £2.9bn.
GlobalData is the parent company of Clinical Trials Arena.