Futibatinib Approval Ushers in Targeted Therapy Option for Patients With Unresectable, Intrahepatic FGFR2-Positive Cholangiocarcinoma

Osheka Hansel, APRN

The approval of futibatinib (Lytgobi) for patients with unresectable, locally advanced or metastatic intrahepatic FGFR2-positive cholangiocarcinoma represents a new, great option for patients who usually face a poor prognosis, according to Osheka Hansel, APRN.

Futibatinib’s approval was supported by findings from the phase 2 FOENIX*-CCA2 trial (NCT02052778). This open-label trial demonstrated that the targeted therapy produced an objective response rate of 42% in this patient population (n = 103). Moreover, the median duration of response was 9.7 months, and 72% of responses endured for 6 months or longer.¹

Futibatinib is an oral medication which is given twice daily. According to Hansel, the ability to provide treatment in the outpatient setting is another advantage, with less time spent in the hospital setting correlating to improvements in patient quality of life.²

“This is an encouraging targeted therapy for qualified patients who typically have limited treatment options,” Hansel, who is an advanced practice nurse at the Florida Cancer Specialists & Research Institute, and a researcher with the Sarah Cannon Research Institute, said in an interview with Oncology Nursing News®. “There are currently many clinical trials investigating how FGFR inhibitors alone and in complement with standard of care systemic chemotherapy can impact patient overall survival. So, I think it’s wonderful. With oral therapy such as futibatinib, patients are not tethered to an institution for infusions, giving them more freedom and better quality of life.”

Expanding on the what the approval represents for patients with unresectable cholangiocarcinoma, Hansel discussed what best practices in adverse event (AE) management will likely entail, and where research must continue to go in order to provide the best care for this patient population.

Oncology Nursing News®: What does this approval mean for patients with FGFR2-mutated cholangiocarcinoma?

Hansel: During the phase 1 and 2 clinical trials of futibatinib, investigators saw the best overall response in patients with cholangiocarcinoma, specifically intrahepatic cholangiocarcinoma. Patients with unresectable disease typically have a very poor prognosis, due to limited treatment options. Futibatinib is targeted therapy specifically for patients with an FGFR2 mutation. For patients, this is a highly selective second-line treatment option that has shown positive results in increasing overall response and survival.

For patients diagnosed with cholangiocarcinoma, the only curative and most favorable treatment option is resection. But if it’s unresectable, systemic chemotherapy is the only treatment option, which is not ideal due to the high potential for adverse effects. To have futibatinib approved as oral therapy, [with] 75% partial response rates in phase I trial, and median progression free survival of 8.9 months, is excellent.

For patients with FGFR2 mutation to qualify for futibatinib, they have to first be treated with platinum therapy; first line [treatment] with gemcitabine and cisplatin and consideration for FOLFOX in the second line.

Please discuss the safety profile of futibatinib. What will best practices look like with bedside nursing?

The most common adverse effects [AEs] of the medication include elevated phosphate levels as well as other electrolyte abnormalities. Gastrointestinal AEs, such as nausea, vomiting, and diarrhea, and poor appetite [can also occur]. Hematologic AEs were also seen—including anemia and thrombocytopenia.

Dermatologic AEs include dry skin, palmar-plantar erythrodysesthesia (hand-foot syndrome) which causes redness, swelling, and pain in the palms and the soles of the feet. [Patients] can also have dry eyes, fatigue, and urinary tract infections.

As a bedside nurse, best practice would be to assess your patients with each contact, asking open-ending questions—keeping in mind the most common AEs. Ask them about their eating habits and whether there are any changes. Assess for weight loss. Are the patient’s labs appropriate? Patient questionnaires listing common AEs may also be beneficial. Does the patient have the pharmaceutical medications at home to manage their symptoms? Discuss findings with the provider.

Education is always key prior to and continually while the patient is being treated. I recommend encouraging the patient to use lubricant after showers and throughout the day to prevent the cracking and the hands and the feet. For dry mouth and to help to prevent that poor appetite, they can suck on hard candies or something sour.

The adverse effects of futibatinib are all things that are manageable, either with lifestyle changes, dose modification/reduction, or discontinuation. Overall, the medication is well tolerated allowing patients to maintain quality of life.

Are there any problems that you have observed in integrating this drug into clinical use? How have you handled that as an institution?

Personally, I have not observed problems integrating this drug into clinic use. Financial barriers typically inhibit clinic use with newer medication. In my experience, they typically come at a higher cost to patients. However, there are usually financial assists available through the manufacturer. Many manufactures provide representatives that can review the financing options with providers. Also, with this being a new medication, some providers may not know it’s available or they may be apprehensive about trying something new.

What questions do you have going forward about safely caring for patients with this drug?

Some of the AEs are directly correlated with the type of medication that it is— an FGFR inhibitor. As treatment progresses patients are going to experience increased phosphate levels and electrolyte abnormalities, I’m interested to see how future research will seek to mitigate these reactions.

References

1. FDA approves Taiho's Lytgobi (futibatinib) tables for previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma. News release. Taiho Oncology, Inc. September 30, 2022. Accessed December 1, 2022. https://prn.to/3y2s7W8
2. Lytgobi. Prescribing information. Taiho Oncology, Inc; 2022. Accessed December 1, 2022. https://bit.ly/3BXxase