Reference Detail

Ref Type

Abstract

PMID

Authors

S. Pant D. Arnold J. Tabernero Y. Loriot G. Folprecht G.M. Haag D. Palmer H. Prenen J. Coward I. Lugowska J-C. Goeminne A. Cervantes M. Gutierrez H. Sweiti C. Hammond S. Najmi S. Thomas S. Triantos L. Crow M.H.H. Schuler

Title

1621P Efficacy and safety of erdafitinib in adults with pancreatic cancer and prespecified fibroblast growth factor receptor alterations (FGFRalt) in the phase II open-label: Single-arm RAGNAR trial

Journal	Vol	Issue	Date	Pages	Journal Short Title
Annals of Oncology	34	Supplement 2	October 2023

URL

https://www.annalsofoncology.org/article/S0923-7534(23)03407-5/fulltext

Abstract Text

Background Erdafitinib (erda) is an oral selective pan-FGFR tyrosine kinase inhibitor approved for treatment of locally advanced or metastatic urothelial carcinoma in adults with susceptible FGFR3/2alt who have progressed during or after ≥1 line of platinum-based chemotherapy. Interim results from the RAGNAR study demonstrated tumor agnostic efficacy in patients (pts) with advanced solid tumors with predefined FGFRalt after failure of standard therapies (tx) (Loriot et al, ASCO 2022 ). Here we report results on pts with pancreatic cancer in RAGNAR. Methods Pts with advanced or metastatic pancreatic cancer with prespecified FGFR1-4alt (mutations or fusions), disease progression after ≥1 line of systemic tx, and who exhausted standard tx received oral erda until disease progression or intolerable toxicity. Primary end point is objective response rate (ORR) by independent review committee (IRC). Secondary endpoints include duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety. Results At data cutoff (median survival f/u 15.24 mo), 18 pts with pancreatic cancer received erda. Median age was 60.5 y (range 34-78); 17 (94.4%) had visceral metastases; median 3 prior lines of systemic tx (range 1-9); 1 (5.6%) responded to last line of tx. All 18-pts had FGFR fusions (14 FGFR2, 4 FGFR1); none had FGFR mutations. None of the pts had KRAS co-alterations. ORR by IRC was 55.6% (95% CI 30.8-78.5). Median time to onset of response was 1.45 mo. Responses were observed in pts with FGFR1 and FGFR2 fusions. Median DCR was 94.4%. Median DOR, PFS and OS were 7.1 mo, 7.0 mo, and 19.7 mo respectively. Investigator-assessed efficacy data were comparable to IRC. The most common adverse events (AEs) were dry mouth (72%), diarrhea (67%), stomatitis (67%), dry skin (67%), hyperphosphatemia (56%), and fatigue (50%); 5 (28%) had serious AEs; 2 (11%) discontinued erda due to AEs. No treatment-related deaths were observed. Conclusions Erda demonstrated robust and clinically meaningful activity in pancreatic cancer pts with FGFRalt. Safety data were consistent with erda safety profile. Clinical trial identification NCT04083976.

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Molecular Profile	Treatment Approach

Gene Name	Source	Synonyms	Protein Domains	Gene Description	Gene Role

Therapy Name	Drugs	Efficacy Evidence	Clinical Trials

Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description

Gene	Variant	Impact	Protein Effect	Variant Description	Associated with drug Resistance

Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
FGFR1 fusion	pancreatic cancer	predicted - sensitive	Erdafitinib	Case Reports/Case Series	Actionable	In a Phase II trial (RAGNAR), Balversa (erdafitinib) treatment resulted in an objective response rate of 55.6%, a disease control rate of 94.4%, median duration of response of 7.1 months, median progression-free survival of 7.0 months, and median overall survival of 19.7 months in patients with pancreatic cancer harboring FGFR1 (n=4) or FGFR2 (n=14) fusions (Ann Oncol (2023) 34 (suppl_2): S898; NCT04083976).	detail...
FGFR2 fusion	pancreatic cancer	predicted - sensitive	Erdafitinib	Phase II	Actionable	In a Phase II trial (RAGNAR), Balversa (erdafitinib) treatment resulted in an objective response rate of 55.6%, a disease control rate of 94.4%, median duration of response of 7.1 months, median progression-free survival of 7.0 months, and median overall survival of 19.7 months in patients with pancreatic cancer harboring FGFR1 (n=4) or FGFR2 (n=14) fusions (Ann Oncol (2023) 34 (suppl_2): S898; NCT04083976).	detail...