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ASLAN's Varlitinib Fails to Meet Endpoint in Phase II Study

Zacks Equity Research

ASLAN Pharmaceuticals Limited ASLN announced that a phase II study, evaluating its pipeline candidate — varlitinib — for the treatment of first-line gastric cancer, failed to meet the primary endpoint of showing significant reductions in tumor size. The study was examining varlitinib plus mFOLFOX6 compared with placebo plus mFOLFOX6 as a first-line therapy for the treatment of HER1/HER2 co-expressing advanced or metastatic gastric cancer.

Data from the study, obtained from an independent central review, proved that patients having received varlitinib + mFOLFOX6 showed an average tumor reduction of 22% compared with the 12.5% decrease for those administered with mFOLFOX6 alone following a 12-week treatment regime. However, this difference did not reach statistical significance.

Notably, the combo of Varlitinib and mFOLFOX6 was well-tolerated in the program. The company also stated that a trend toward an improvement in progression free survival was observed in the study.

Shares of ASLAN have plummeted 51.3% in the past six months, wider than the industry’s decrease of 14.1%.

Varlitinib is an oral, reversible, small molecule pan-HER inhibitor targeting the human epidermal growth factor receptors HER1, HER2 and HER4. Apart from gastric cancer, the candidate is being studied for biliary tract, breast and colorectal cancers.

Varlitinib enjoys an orphan drug designation in the United States for gastric cancer and cholangiocarcinoma, a sub-type of biliary tract cancer (BTC).

We would like to remind investors that earlier this month, ASLAN completed patient enrolment in the global TreeTopp study, analyzing a combination of varlitinib and Roche’s RHHBY Xeloda (capecitabine) as compared to Xeloda plus placebo for second-line biliary tract cancer. Top-line results from the study are expected in the second half of 2019.

Another cancer candidate in ASLAN’s portfolio is ASLAN003, currently being developed as a potential treatment for acute myeloid leukaemia (AML). The company plans to begin a phase II study in the United States during the first half of 2019.

Zacks Rank & Stocks to Consider

ASLAN carries a Zacks Rank #3 (Hold) at present. Better-ranked stocks in the healthcare sector include Vanda Pharmaceuticals Inc. VNDA and Acorda Therapeutics, Inc. ACOR, both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Vanda’s earnings estimates have moved 11.1% north for 2019 over the past 90 days. The stock has surged 46.1% in the past six months.

Acorda’s loss per share estimates have been narrowed 1.9% for 2019 in the last 90 days.

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