Fruzaqla Approval Has ‘Impressive’ Survival Benefit in Metastatic CRC

The recent Food and Drug Administration (FDA) approval of Fruzaqla (frutquintinib) for patients with pretreated metastatic colorectal cancer (mCRC) led to “impressive” survival improvements, according to an expert.

The approval was for patients with mCRC who underwent standard of care treatment re chemotherapy with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy and an anti-EGFR monoclonal antibody.

The safety and efficacyiency of Fruzaqla was demonstrated in a recent FRESCO-2 trial. The study included 691 patients, all of which had s mCRC and had had evidence of showed signs of disease progression during or after fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy or , an anti-EGFR antibodyleast one trifluridine/tipiracil or Stivarga (regorafenib).

The main objective of the study was to analyze overall survival. (OS, the time which begins at diagnosis — or at the start of treatment — and up until time of death).

“So what they saw was that this improved overall survival to 7.4 months versus 4.8 months in the placebo group, which is very impressive since 73% of the patients had received more than three lines of chemotherapy. At that point, you would think that the tumors are resistant to any more systemic therapy. This is really exciting for patients who now have another option in their treatment journey and I think that this is going to be really beneficial for patient,” stated Dr. Dulabh Monga, Aassociate Pprofessor in the Department of Medicine at Drexel University College of Medicine and medical oncology lead for colorectal and pancreatic cancer at Allegheny Health Network Cancer Institute, in a recent interview with CURE®.

Within the study, patients were randomly assigned to the Fruzaqla group or the placebo group. Patients received therapy until disease progression or toxicity.

“Fruquintinib is an oral drug that is highly selective and potent, which means that it really targets the receptors that are called the vascular endothelial growth factor receptors 1,2 and 3., one, two and three. And what that means is that it inhibits the micro-vessel formation that supplies tumors. In essence, you would say that it starves the tumors of their blood supply and that's how it works,” noted Dr. Monga.

“Fruzaqla also revealed some side effects within the study. When patients are progressing on therapies, they can show signs of weakness and tiredness due to previous chemotherapies before.is well tolerated but has some side effects such as high blood pressure, fatigue, hoarseness of voice, abdominal pain, diarrhea and hand foot syndrome that can manifest as a rash. However these side effects are manageable. For example hand-foot syndrome can be managed with liberal moisturization and patients can continue to function and do their daily activities and high blood pressure can be managed with medications,” said Dr Monga.

“With this drug, what was some of the side effects, so what we saw was high blood pressure. You can imagine, because it's targeting the blood vessels, you can develop high blood pressure. It wasn't in all patients; it was in about 15% of patients. The other thing is some fatigue, patients did develop some fatigue, but also that was in about 8 or 9% of patients. The other interesting side effect that some of these patients develop was something called hand foot syndrome, where you can get a rash on your hands and feet, but it's easily controllable. If patients moisturize their hands and feet liberally, you can actually prevent hand and foot syndrome from developing, or you can even control it that in that they can still continue to function and do their daily activities,” said Monga.

The clinical study also focused on quality of life within the patient population.

“Questionnaires are sent to patients to make sure that they're maintaining theassess their quality of life. Qand quality of life was maintained in about 65% of patients in both arms, placebo and in the Fruzaqla arm, which is pretty good. And I think that this is a very exciting drug, a new option for patients with metastatic colon cancer, who have progressed on all the standard-of-care therapies,” noted Dr. Monga.

Although Fruzaqla is being used as a single agent, trials are being studied to advance the drug, according to Monga.has been approved as a single agent, there is more to look forward in the future.

“There are trials that are being designedone that are looking at combination therapies with chemotherapy and moving it into earlier lines of therapy, so those trials are ongoing. We need novelmore and more drugs and more options for patients so they can live longer.”

Consultations with doctors are extremely important when treatments with new medications occur. Monga said that it is important for patients to work closely with their medical professionals to gain knowledge about the cancer and discuss new treatment options that may be available to them.

“Continue to remain positive and consult with your their doctors, continue to check the (American Society of Clinical Oncology’s) website. There are numerous oncology websites that patientsthey can continue to consult and see what's new out there. Hopefully, as we do more and more research and understand the underlying mechanisms of cancer, more drugs will be coming along the pipeline and there will be more opportunities for patients to get novel treatments,” stated Dr. Monga.

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