Onvansertib

Actuate Therapeutics' elraglusib reduced death risk by 37% in a Phase I/II metastatic pancreatic cancer trial, doubling one-year survival rate to 43.6% in the treatment arm vs 22.5% in the control arm. The company plans a Phase III study based on these encouraging results.

Cardiff Oncology's onvansertib, a PLK1 inhibitor, showed 64% ORR in a phase II study for first-line RAS-mutated mCRC, with 57% overall ORR. The 30 mg dose demonstrated greater tumor size reduction and similar safety profiles. The company plans a phase III study based on these results.

Cardiff Oncology reports promising Phase 2 trial results for onvansertib in first-line RAS-mutated metastatic colorectal cancer, showing higher overall response rates compared to standard treatments alone.

Cardiff Oncology announced positive Phase II data for onvansertib in RAS-mutated mCRC, showing 64% ORR in the 30mg dose arm. The stock price surged 50% following the results, and the company plans to use $40m from an oversubscribed offering to fund clinical costs and other purposes.

Onvansertib plus FOLFIRI/bevacizumab showed increased clinical activity in second-line treatment of KRAS-mutated metastatic colorectal cancer, with a 26.4% overall response rate. Patients without prior bevacizumab exposure had a 76.9% ORR and median PFS of 14.9 months, leading to study termination early. The regimen is now being evaluated as a first-line therapy.

DelveInsight's report on KRAS Inhibitors covers market trends, epidemiology, and pipeline developments in the US, EU4, UK, and Japan. The market is driven by cancer incidence and personalized treatments, with key companies like Novartis, Roche, and Verastem Oncology leading in KRAS inhibitor therapies.

The KRAS Inhibitors market is poised for significant growth driven by increasing cancer incidence, treatment access, and a robust pipeline. The market size in the 7MM was $500 million in 2023, expected to rise by 2034. KRAZATI (adagrasib) is projected to outperform LUMAKRAS (sotorasib) in revenue. The US leads in KRAS mutation cases in NSCLC, with 46% of 7MM cases. Competition in G12C NSCLC is intensifying, with Chinese biotechs entering the KRAS space. Despite G12D being the most prevalent KRAS variant, G12C is the primary target in colorectal cancer. KRAZATI is the first KRAS inhibitor approved for KRAS G12C-mutant colorectal cancer. Pancreatic cancer, with 60-90% KRAS mutations, presents a significant market opportunity. Pan-KRAS drugs, targeting multiple mutations, offer broad market potential. Key companies include Novartis, Roche, Genentech, and Mirati Therapeutics. Emerging therapies like JDQ443, Divarasib, and Avutometinib are expected to reshape the market. The KRAS inhibitor market is evolving, driven by high unmet needs, competitive drug development, and regulatory approvals.

First patient dosed in ONSEMBLE Phase 2 trial of Onvansertib for KRAS/NRAS-mutated mCRC. SAB full membership introduced. Fairooz Kabbinavar appointed as CMO. $97 million in cash, equivalents, and short-term investments as of March 31, 2023, with runway into 2025.