AVEO Announces Preliminary Results Of Exploratory Phase 2 Study Evaluating HGF Inhibitor In First-Line Patients With Advanced Lung Cancer

AVEO Pharmaceuticals Inc. (NASDAQ: AVEO) announced today preliminary data from the exploratory, randomized Phase 2 study comparing the combination of ficlatuzumab and gefitinib, an EGFR tyrosine kinase inhibitor (TKI), to gefitinib monotherapy in previously untreated Asian subjects with non-small cell lung cancer (NSCLC), a population with a high prevalence of EGFR sensitizing mutations (SM+). In this study, encouraging signals of activity were observed in unique subsets of patients based on EGFR mutation status and c-Met expression level. EGFR TKI therapies are the standard of care for patients with EGFR SM+.

“Some patients with EGFR sensitizing mutations do not respond well to EGFR TKI therapy,” stated Tony Mok, M.D., professor, Department of Clinical Oncology, The Chinese University of Hong Kong, and senior investigator of the Phase 2 trial. “This study has uncovered an important subset of patients with non-small cell lung cancer that may be underserved by EGFR TKIs. Patients with EGFR sensitizing mutations and low c-Met expression levels treated with the combination of ficlatuzumab and gefitinib lived twice as long without their disease progressing compared to those treated with gefitinib alone. These data support a potential benefit from combining an EGFR targeted therapy with ficlatuzumab and warrant further investigation in lung cancer.”

The primary endpoint of the study was overall response rate (ORR), and progression free survival (PFS) was a secondary endpoint. Preliminary results in the intent-to-treat (ITT) population (n=94 each arm) showed a trend favoring the ficlatuzumab/gefitinib combination; however, as with data from Phase 2 studies in NSCLC with other inhibitors of the Met pathway, study results in the ITT population did not reach statistical significance. In the ITT population, ORR was 43% for the ficlatuzumab/gefitinib combination arm versus 40% for the gefitinib monotherapy arm, and median PFS was 5.6 months versus 4.7 months for the ficlatuzumab/gefitinib combination arm versus the gefitinib monotherapy arm, respectively, favoring the combination arm.

Encouraging signals of activity were observed in biomarker subset populations. Key findings are summarized in the following chart:

Biomarker Subset		Ficlatuzumab/Gefitinib Combination								Gefitinib Alone
		# ofSubjects		Median PFS(months)		ORR,%				# ofSubjects		Median PFS(months)		ORR,%
EGFR SM+/c-Met Low		10		11.0		70				9		5.5		44
EGFR SM+/c-Met High		23		9.2		52				27		9.2		63
EGFR SM-/c-Met Low		9		1.3		0				13		2.3		0
EGFR SM-/c-Met High		11		1.8		27				16		1.8		13

No clinically meaningful differences in adverse event rates between the combination and monotherapy arms were observed, and the combination was well-tolerated. Complete data from this trial, which will include biomarker analyses, are anticipated to be submitted for presentation at an upcoming medical meeting in the second half of this year.

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