Found 1 Presentation For Request "51P"

Biliary tract cancer, incl. cholangiocarcinoma

51P - Pooled analysis safety profile of futibatinib in patients with advanced solid tumors, including intrahepatic cholangiocarcinoma (iCCA)

Presentation Number
51P
Speakers
  • Funda Meric-Bernstam (Houston, TX, United States of America)

Abstract

Background

Futibatinib, an irreversible FGFR1–4 inhibitor, has shown efficacy in iCCA with FGFR2 fusions/rearrangements and antitumor activity in advanced solid tumors, along with a manageable safety profile. This integrated safety analysis evaluated the safety profile of futibatinib 20 mg QD (the recommended phase II dose) in an expanded patient (pt) population across tumor types.

Methods

Pts who received ≥1 futibatinib dose at 20 mg QD in a global phase I/II (NCT02052778) and a Japanese phase I study (JapicCTI-142552) were included in this retrospective analysis. AEs, treatment (tx)-related AEs (TRAEs), AEs of special interest (AESIs), and time to onset/resolution (TTO/TTR) of AESIs were analyzed.

Results

As of October 1, 2020, 318 pts had received futibatinib 20 mg QD across trials (median [m] duration, 111 d). The most common tumor types were CCA (60%), primary CNS tumors (11%), and gastric cancer (9%); 98% had received ≥1 prior tx. Overall, 43% of pts experienced grade (gr) 3 TRAEs, and 1% gr 4 TRAEs; no gr 5 TRAEs were reported. The most frequent gr ≥3 TRAE was hyperphosphatemia (in 23%; defined as ≥7 mg/dL serum phosphate), followed by increased alanine aminotransferase (6%) and increased aspartate aminotransferase (5%). Gr ≥3 diarrhea (<1%), nausea (1%), stomatitis (3%), and fatigue (3%) were rare. Nearly all cases of gr 3 hyperphosphatemia resolved (73/75; mTTR, 7 d) with phosphate binders and dose adjustments. Other AESIs were mostly mild to moderate in severity (nail toxicities [gr ≥3: 1%], hepatotoxicity [gr ≥3: 12%], and palmar-plantar erythrodysesthesia [gr ≥3: 3%]); most gr ≥3 events resolved. Retinal toxicities occurred in 8% of pts (all gr 1–2), and 2% had a TRAE of cataract (gr ≥3: 1%). Management of TRAEs included dose adjustments (54% of pts). Overall, 3% of pts discontinued tx due to TRAEs (only diarrhea and stomatitis in >1 pt [n=2 each]; none due to hyperphosphatemia). No obvious differences in safety were noted between tumor types.

Conclusions

Futibatinib was safe and tolerable in this pooled analysis of pts with advanced solid tumors. In the majority of pts, TRAEs were gr 1–2 in severity, and most gr ≥3 events resolved with adequate management. Tx-related discontinuations were rare.

Clinical trial identification

NCT02052778 JapicCTI-142552.

Editorial acknowledgement

Medical writing support for the development of this manuscript, under the direction of the authors, was provided by Vasupradha Vethantham, PhD, and Divya Kernik, PhD, and editing support was provided by Jennifer Robertson, PhD, all of Ashfield MedComms, an Ashfield Health company, and funded by Taiho Oncology, Inc.

Legal entity responsible for the study

Taiho Oncology, Inc.

Funding

Taiho Oncology, Inc.

Disclosure

F. Meric-Bernstam: Financial Interests, Institutional, Research Grant: Taiho Oncology, Aileron Therapeutics AstraZeneca, Bayer Healthcare, Calithera Biosciences, Curis, CytomX Therapeutics, Daiichi Sankyo, Debiopharm, eFFECTOR Therapeutics, Genentech, Guardant Health, Klus Pharma, Takeda Pharmaceutical, Novartis, Puma Biotec; Financial Interests, Personal, Advisory Role: AbbVie, Aduro BioTech, Alkermes, AstraZeneca, Debiopharm, eFFECTOR Therapeutics, F. Hoffmann La Roche, Genentech, IBM Watson, Infinity Pharmaceutical, Jackson Laboratory, Kolon Life Science, OrgiMed, PACT Pharma, Parexel International, Pfizer Inc, Samsung; Financial Interests, Personal, Invited Speaker: Chugai Biopharmaceuticals; Financial Interests, Personal, Advisory Board: Immunomedics, Inflection Biosciences, Mersana Therapeutics, Puma Biotechnology, Seattle Genetics, Silverback Therapeutics, Spectrum Pharmaceuticals, Zentalis. J. Furuse: Financial Interests, Personal, Research Grant: Ono Pharmaceutical, MSD, Merck Bio, J-Pharma, Taiho Pharmaceutical, Takeda, Chugai Pharma, AstraZeneca, Yakult Honsha, Eisai, Daiichi Sankyo, Mochida, Sanofi, Sumitomo Dainippon Bayer, Astellas, Incyte Japan; Financial Interests, Personal, Speaker’s Bureau: Ono Pharmaceutical, Bayer, Eisai, Eli Lilly Japan, MSD, Yakult Honsha, Chugai Pharma, Novartis Pharma, AstraZeneca, Pfizer, Takeda Taiho Pharmaceutical, Sanofi, Mylan EPD, EA Pharma, Kyowa Hakko Kirin, Daiichi Sankyo, Teijin pharma, Servier Japan, Incyt; Financial Interests, Personal, Advisory Board: Fuji film, Mudi Pharma, Onco Therapy Science, Merck Bio, Ono Pharmaceutical, MSD, Taiho Pharmaceutical, Chugai Pharma, Astellas, AstraZeneca, Takara bio, Delta-Fly-Pharma, Incyte Japan. D. Oh: Financial Interests, Personal, Research Grant: AstraZeneca, Novartis, Array, Eli Lilly, Servier, BeiGene, MSD, Handok; Financial Interests, Personal, Advisory Board: AstraZeneca, Novartis, Genentech/Roche, Merck Serono, Bayer, Taiho, ASLAN, Halozyme, Zymeworks, BMS/Celgene, BeiGene, Basilea, Turning Point. J.A. Bridgewater: Financial Interests, Personal, Advisory Board: Taiho Oncology, Inc.; Financial Interests, Personal, Advisory Role: Taiho Oncology, Inc..L. Goyal: Financial Interests, Institutional, Research Grant: Agios, Adaptimmune, Bayer, Eisai, Merck, Macrogenics, Genentech, Novartis, Incyte, Eli Lilly, Loxo Oncology, Relay Therapeutics, QED Therapeutics, Taiho Oncology, Leap Therapeutics, Bristol Meyers, Squibb, Nucana.; Financial Interests, Personal, Advisory Role: Agios Pharmaceuticals Inc, Alentis Therapeutics, Genentech, Exelixis, Incyte Corporation, QED Therapeutics, Sirtex Medical Ltd, Taiho Oncology Inc.; Financial Interests, Personal, Advisory Board: AstraZeneca. K. Li: Financial Interests, Personal, Full or part-time Employment: Taiho Oncology, Inc.. P. Patel: Financial Interests, Personal, Full or part-time Employment: Taiho Oncology, Inc..N. Soni: Financial Interests, Personal, Full or part-time Employment: Taiho Oncology, Inc.. V. Wacheck: Financial Interests, Personal, Full or part-time Employment: Taiho Oncology, Inc.. M. Moehler: Financial Interests, Personal, Research Grant: EORTC, AIO, German Cancer Aid, BMBF; Non-Financial Interests, Personal, Other: EORTC, AIO, German Cancer Aid, BMBF, Amgen, Bristol Myers Squibb; Financial Interests, Institutional, Research Grant: MSD, Pfizer, Amgen, Bristol-Myers Squibb, Merck Serono; Financial Interests, Personal, Other: Falk Foundation, Lilly, MSD, Roche, Pfizer, Amgen, Bristol-Myers Squibb, Merck Serono, MCI Group, Taiho. All other authors have declared no conflicts of interest.

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