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ASLAN Pharmaceuticals Limited (ASLN)

NasdaqGM - NasdaqGM Real Time Price. Currency in USD

9.21+2.36 (+34.45%)

At close: 4:00PM EDT

9.10 -0.11 (-1.19%)66

After hours: 5:50PM EDT

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(Bloomberg) --

BTIG LLC initiated coverage of Aslan Pharmaceuticals Ltd.¡¦s American depository receipts with a recommendation of buy.

PT set to $16, implies 134% increase from last close. Aslan Pharmaceuticals average PT is $14.50

Aslan Pharmaceuticals Ltd (NASDAQ: ASLN) received a Buy rating and a $12 price target from H.C. Wainwright analyst Ram Selvaraju today. The company¡¦s shares closed yesterday at $6.85, close to its 52-week high of $6.94.

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Leerink Partners LLC initiated coverage of Aslan Pharmaceuticals Ltd.¡¦s American depository receipts with a recommendation of market perform.

PT set to $7, implies 2.2% increase from last close. Aslan Pharmaceuticals average PT is $12

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A 2018 ASCO :

Dose finding study of varlitinib ¡Ó trastuzumab with carboplatin/paclitaxel in advanced solid tumors.

This is a phase 1b dose confirmation study to determine safety and early efficacy signals of V ¡Ó T combined with weekly P 80mg/m2 and C AUC = 2

2018 06 04 ASCO ¬ã¨sµoªí µ²½×¬Ý¥X weekly V ¡Ó T combined with P 80mg/m2 and C AUC = 2

µo²{¥[¶PÀù¥­¬O¦w¥þªº , Aslan 001 ¦b±ÀÂ˾¯¶q¤U»P¤Ó¥­¬vµµ§ü¾J¹ï HER2 ¶§©Ê¨ÅÀù¬O¦³®Äªº ,

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Conclusions: The RD of V combined with P is 300mg BD int, and is active in HER2+ MBC; T can be added safely. The triple combination will be evaluated as neoadjuvant therapy in HER2+ breast cancer

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Official Title:

Phase Ib Dose-confirmation Study of ASLAN001 Combined With Weekly Paclitaxel and Carboplatin in Advanced Solid Tumours, Followed by an Open-label Phase II Study in Patients With Stage I-III HER2 Positive Breast Cancer

Study Start Date : March 2015

Estimated Primary Completion Date : March 2018

Estimated Study Completion Date : March 2019

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Drug: Paclitaxel + Carboplatin + ASLAN001

Phase I

IV Paclitaxel 80mg/m2, day 1, 8, 15 of a 21-day cycle

IV Carboplatin AUC of 1.5, day 1, 8, 15 of a 21-day cycle

PO ASLAN001 daily continuously (starting dose 500mg BID)

Phase II

•PO ASLAN 001 daily continuously at the recommended phase II dose x 2 weeks

Followed by:

IV Paclitaxel 80mg/m2, day 1, 8, 15 of a 21-day cycle x 4 cycles

IV Carboplatin AUC of 1.5, day 1, 8, 15 of a 21-day cycle x 4 cycles

PO ASLAN001 daily continuously at the recommended phase II dose x 12 weeks

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MBC¼Æ¾Ú:20/37 had HER2+ metastatic breast cancer (MBC) with median 4 (0-14) prior treatment lines. 7 achieved partial response (PR) and 3 stable disease (SD); 6 had disease control with single agent V for a median 7.0 more months (4.3 ¡V 13.3) after chemotherapy ceased. 2/17 with other tumor types achieved PR (HER2- MBC = 1, NSCLC = 1). 3/10 patients (HER2+ MBC = 2) in the V 300mg BD int cohorts achieved PR. No correlation was seen between V and P mean AUC (ng.h/mL) in those with and without DLTs (V 10336.5 vs 20758.8, p = 0.21; P 4882.1 vs 5197.6, p = 0.77). No interaction was seen between V dose/schedule with P PK. Conclusions: The RD of V combined with P is 300mg BD int, and is active in HER2+ MBC; T can be added safely. The triple combination will be evaluated as neoadjuvant therapy in HER2+ breast cancer.

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Results

From Dec 2014 to Aug 2016, 24 patients were randomized to the VC arm (400mg BID) and 26 to the LC arm (1250mg QD) in 16 sites in 6 countries. Percentage of tumor size reduction was numerically higher in VC than LC (-31.00% vs. -19.37%, one-sided p = 0.132). ORR in the VC arm (40.9%) was similar to LC arm (45.5%), p = 1.000. Sensitivity analysis showed numerically superior ORR and statistically significant higher reduction of tumor size in VC compared to LC (60% vs. 45.5%, p = 0.508; mean, -34.6% vs.-19.4%, one-sided p = 0.075) All patients had at least 1 AE. Severe AE(s) were observed in 13 patients (54.2%) in the VC arm and 11(42.3%) in the LC arm. The most common AE was diarrhea (66.7%) in the VC arm and were diarrhea and palmar-plantar erythrodysaesthesia syndrome (both 50%) in the LC arm. Median intended exposure and percentage of intended dose were lower in the VC arm (115.5 days, 74.6%) indicating more frequent dose interruption, dose reduction and treatment discontinuation than the LC arm (135.0 days, 99.05%).

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