The chronicles of Aslan Pharmaceuticals keep reading as a tragedy as the Singapore-based cancer biotech is hit with another failure for its key pipeline hope.
This time around, varlitinib, an oral small-molecule pan-HER inhibitor, failed its pivotal test in second-line biliary tract cancer (BTC) patients.
In a top-line peek at the data, Aslan reports: “Varlitinib did not met the primary endpoints of progression-free survival (PFS) and overall response rate (ORR) as assessed by ICR according to RECIST.”
The double-blind, randomized two-arm study enrolled 127 patients who had failed first-line therapy from 56 sites across the globe.
The median PFS was 2.83 months for the varlitinib in combination with chemo agent Xeloda (capecitabine) arm of the study versus a median PFS of 2.79 in the control arm. ORR was 9.4% in the varlitinib arm versus 4.8% in the control arm.
And you can already hear the collective groans of Bio-Twitter, but Aslan did some data dredging and found a subgroup “which appeared to show improved efficacy.”
It added: “This finding has been supported by retrospective review of the JADETREE study which tested varlitinib in combination with capecitabine in second line BTC patients in China.”
More analysis is “ongoing,” but it looks like the focus is shifting onto its other pipeline assets.
Carl Firth, Ph.D., CEO of Aslan, said: “The results from the study are disappointing. They will, however, provide the scientific community with important insights into an aggressive and under-researched disease that presents a growing burden of care worldwide as prevalence rises.
“I would like to extend our thanks to the patients, trial investigators and site personnel who participated in the study and to the ASLAN team for their commitment to the development of varlitinib. Aslan remains focused on the promising molecules in its portfolio, including the ongoing study in atopic dermatitis of ASLAN004, our IL-13 receptor antibody which blocks signalling through IL-4 and IL-13. We look forward to the interim readout in early 2020.”
This comes after another flop for the drug back in January when varlitinib failed to improve outcomes in a phase 2 study of patients with metastatic gastric cancer. The news drove a double-digit drop in Aslan’s share price and wiped out one of the prospects that helped it limp to a downsized $42 million Nasdaq IPO last year.
A few weeks after this, Aslan posted plans to cut its head count by 30%, with the layoffs halving operational costs.
Shares in the company were down 21% on the Nasdaq premarket Monday morning, before dropping 60% when the market opened.