{"id":474580,"date":"2021-04-12T06:03:33","date_gmt":"2021-04-12T10:03:33","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/cardiff-oncology-announces-onvansertib-phase-1b-2-data-that-continues-to-demonstrate-robust-response-to-treatment-and-progression-free-survival-in-kras-mutated-mcrc\/"},"modified":"2021-04-12T06:03:33","modified_gmt":"2021-04-12T10:03:33","slug":"cardiff-oncology-announces-onvansertib-phase-1b-2-data-that-continues-to-demonstrate-robust-response-to-treatment-and-progression-free-survival-in-kras-mutated-mcrc","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/cardiff-oncology-announces-onvansertib-phase-1b-2-data-that-continues-to-demonstrate-robust-response-to-treatment-and-progression-free-survival-in-kras-mutated-mcrc\/","title":{"rendered":"Cardiff Oncology Announces Onvansertib Phase 1b\/2 Data that Continues to Demonstrate Robust Response to Treatment and Progression-Free Survival in KRAS-Mutated mCRC"},"content":{"rendered":"
\n

– 7 of 18 (39%) evaluable patients in the Phase 1b\/2 trial have achieved a partial response to-date<\/h2>\n

– Evaluable patients have a median progression free survival (mPFS) of 9.4 months, more than double the historical 4.5-month mPFS from analysis of 23 randomized trials in second-line metastatic colorectal cancer (data from ~10,800 patients)\u00b9<\/h2>\n

– Decreases in KRAS mutant allelic frequency after the first cycle of treatment continues to be predictive of subsequent tumor shrinkage<\/h2>\n

– Onvansertib in combination with FOLFIRI\/bevacizumab has been well tolerated with no major or unexpected toxicities attributed to onvansertib<\/h2>\n

PR Newswire<\/p>\n<\/p><\/div>\n

\n

\n SAN DIEGO<\/span>, April 12, 2021<\/span> \/PRNewswire\/ —\u00a0Cardiff Oncology, Inc. <\/b>(Nasdaq:\u00a0CRDF), a clinical-stage biotechnology company developing onvansertib to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, pancreatic cancer and castrate-resistant prostate cancer, today announced data from its ongoing Phase 1b<\/span>\/2 trial that demonstrate the continued robust patient response to treatment with onvansertib and progression-free survival when combined with standard-of-care therapy in second line KRAS-mutated metastatic colorectal cancer (mCRC). <\/p>\n

\n

\n
\n \"Cardiff
\n <\/a>\n <\/p>\n<\/p><\/div>\n

Patients enrolled in the ongoing Phase 1b<\/span>\/2 trial receive onvansertib in combination with standard-of-care FOLFIRI and Avastin\u00ae<\/sup><\/span> (bevacizumab). The overall response rate (ORR) in the trial is 39% to-date, and onvansertib in combination with FOLFIRI\/bevacizumab has been well tolerated with no major or unexpected toxicities attributed to onvansertib. The median progression free survival (mPFS) of evaluable patients is 9.4 months. This represents an increase over the mPFS observed in a systematic literature-based analysis of second line mCRC clinical trial data from 23 randomized trials including a total of ~10,800 patients (mPFS of 4.5 months)1<\/sup> and the 5.7-month mPFS observed in the pivotal trial that supported the regulatory approval of FOLFIRI plus bevacizumab in second line mCRC2<\/sup>.<\/p>\n

“As we have continued to collect data from this ongoing trial, we have consistently seen an impressive and durable response to treatment, and a favorable safety and tolerability profile,” said Daniel H. Ahn<\/span>, D.O., lead investigator and medical oncologist, Mayo Clinic Cancer Center,\u00a0Arizona. “Notably, the ORR and mPFS observed in the trial compare very favorably to what has been seen historically in second line mCRC patients. These promising results highlight the potential of onvansertib to address the unmet needs in mCRC, and I look forward to discussing them in detail during Cardiff Oncology’s upcoming key opinion leader webinar.”<\/p>\n

\n Mark Erlander<\/span>, Ph.D., chief executive officer of Cardiff Oncology added, “We are very pleased with the results to-date from our Phase 1b<\/span>\/2 mCRC trial. In addition to continuing to show a consistent and robust response rate, we have also reported intriguing biomarker analyses highlighting the potential of plasma KRAS mutant allelic frequency as a tool to predict patient response to onvansertib. We look forward to providing results from the Phase 2 trial later this year.”<\/p>\n

\n Highlights from the updated data announcement include:<\/b>\n <\/p>\n

\n Efficacy:<\/i>\n <\/p>\n