Biotech
Tuesday, July 5th, 2022 11:12 am EDT
Dive Brief:
- Seagen reported new study results indicating its targeted cancer drug, Tukysa, might benefit certain patients with advanced colorectal cancer.
- Phase 2 trial data reported at a medical meeting in Europe over the weekend show that 38% of study volunteers, each of whom had HER2-positive colorectal cancer and previously received other therapies, responded to treatment with Tukysa and the Roche drug Herceptin. Treatment helped keep cancers from progressing for a median of about 8 months and kept patients alive a median of roughly 24 months, Seagen said.
- The results build on initial findings reported in May and are meant to expand use of Tukysa, which is already approved to treat metastatic breast cancer. There are no targeted treatments available for HER2-positive colorectal tumors, though that could soon change, as Seagen has said it plans to file for accelerated approval in the U.S.
Dive Insight:
The data update provides Seagen with a boost during a tumultuous time.
The company’s longtime CEO, Clay Siegall, resigned in May amid an investigation into domestic abuse allegations. Last month, the Wall Street Journal reported the company may soon sell itself to Merck & Co., which already owns a stake in Seagen and partial rights to Tukysa as part of a deal the two struck in 2020.
What’s more, despite having four products on the market, the company still isn’t consistently profitable. It revised its revenue projections for Tukysa earlier this year due to growing competition, mainly from AstraZeneca and Daiichi Sankyo’s rival breast cancer drug Enhertu.
Expanding Tukysa’s label could help boost those numbers. The drug is currently only approved to treat advanced breast cancers that express the protein HER2, an indication that led to $334 million in sales last year. But the medicine is in clinical testing for other tumors as well. Its closest market opportunity is in HER2-positive colorectal tumors. Though the protein is believed to be overexpressed on only 3% to 5% of colorectal cancers, approval in that setting could nonetheless add up to $542 million in additional yearly revenue, according to SVB Securities analyst Andrew Berens.
The new results demonstrate “encouraging durability that could position the combination as standard of care,” Berens wrote in a note to clients. The regimen’s impact on tumor progression and survival surpass what was reported in a study of Herceptin and the GSK cancer medicine Tykerb in a study published in The Lancet Oncology in 2016, for instance. Side effects, most commonly diarrhea, fatigue and nausea, were consistent with what was previously reported. Adverse events led 5.8% of study volunteers to drop out of the trial, Seagen said.
Seagen is also testing a regimen of Tukysa, Herceptin and chemotherapy to chemo alone in a Phase 3 study in patients newly diagnosed with metastatic disease. That study would serve as a confirmatory trial if regulators grant Tukysa an accelerated approval for colorectal tumors.
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