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Compass Therapeutics' ABL Bio-partnered bispecific antibody met its primary endpoint in a pivotal trial for advanced biliary tract cancer (BTC), tripling chemo’s response rate—and the company is wasting no time arranging FDA discussions.
In the randomized phase 2/3 COMPANION-002 trial, Compass’ antibody tovecimig (ABL001/CTX-009), licensed from Korea’s ABL Bio, posted a 17.1 percent overall response rate when paired with paclitaxel, compared to 5.3 percent for chemo alone. The result cleared the statistical bar with a p-value of 0.031 and included one confirmed complete response.
Now, Compass is aiming to meet with the FDA this quarter to lay the groundwork for a potential license application, with CEO Thomas Schuetz telling investors—on Tuesday’s call delayed by a day—that the goal is to get regulators’ read on the data and “have an initial conversation on the dataset that might support” approval.
Tovecimig combined with paclitaxel delivered a 17.1 percent response rate in second-line biliary tract cancer, significantly outperforming chemo alone at 5.3 percent. (Credit: Getty Images)
Tovecimig combined with paclitaxel delivered a 17.1 percent response rate in second-line biliary tract cancer, significantly outperforming chemo alone at 5.3 percent. (Credit: Getty Images)
The 168-patient study enrolled individuals with advanced or recurrent BTC who had failed first-line chemotherapy. Patients were randomized 2:1 to receive paclitaxel alone or in combination with tovecimig, a DLL4/VEGF-A bispecific. While Handok retains rights in Korea through a license deal with ABL Bio, Compass holds global rights outside the country.
Beyond the response rate delta, early disease control tilted heavily in Compass' favor. By week eight, 42.1 percent of patients on chemo alone had progressed. In the tovecimig arm, that number fell to 16.2 percent.
Four patients in the treatment arm saw 100 percent reductions in tumor burden. One was confirmed as a complete response; the other three, partials, due to “some subtle differences in their non-target lesions—something that is commonly seen in these studies,” Schuetz noted. The significant difference in progressive disease rates, combined with this waterfall plot, gives the company confidence in the progression-free survival analysis, he added.
Even so, key survival endpoints remain pending. The trial hasn’t yet accrued the number of events needed to evaluate overall survival or duration of response. Compass expects to report those secondary endpoints, along with full safety data, in the fourth quarter.
“Our base case has always been that the full trial results would be required,” Schuetz said, when asked about the odds of an accelerated pathway. But repeating the study could prove difficult, he added, suggesting the company may move upstream into frontline treatment. A trial led by MD Anderson is already testing tovecimig in combination with gemcitabine, cisplatin and checkpoint inhibitor durvalumab, to evaluate tovecimig as a first-line treatment.
BTC is among the most lethal solid tumors, with few treatment options and a low prevalence of targetable mutations. Just 15 percent of patients qualify for existing precision therapies, Schuetz said. The other 85 percent—the target for Compass’ drug—are left with FOLFOX, which showed a 4.9 percent ORR in prior phase 3 data.
Compass is positioning tovecimig to fill that gap. The biotech estimates about 23,000 BTC diagnoses annually in the U.S., and sees the DLL4-expressing tumor space as a broader opportunity. Tovecimig is "the only bispecific to our knowledge to demonstrate monotherapy activity in GI solid tumors," Schuetz said.
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Kim Ji-hye jkim404@docdocdoc.co.kr
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