Racing ahead of Merck and Innovent, Junshi declares PhIII success on cancer that won them 'breakthrough' status
Early this month, the FDA handed Junshi Biosciences an agency first: A breakthrough designation for a PD-(L)1 therapy out of China. Now, the Shanghai-based biotech is declaring pivotal success.
Junshi said Tuesday that, in an interim analysis, their lead drug Toripalimab had improved progression free survival for patients with recurrent or metastatic forms of a rare cancer called nasopharyngeal carcinoma. Junshi did not release any numbers, but the 2-year-long Phase III study, comparing chemotherapy and toripalimab to chemo alone, had been set to enroll 280 patients.
The biotech said they would submit for approval in China shortly, with other countries following soon after. The news positions Junshi to be the first to gain approval in a tumor that, while overlooked through much of the PD-1 race, is also now being pursued by Merck and Innovent.
Junshi has long been one of the top PD-1 competitors in China. In 2018, they won the country’s first home-grown PD-1 approvals, taking home a $394 million IPO in the process, beating out Innovent and BeiGene. BeiGene, though, snared the first US approval for a Chinese drug developer and Innovent has partnered with Eli Lilly to get their own US okay.
PD-1s are entrenched enough by now that breakthrough designations — for US or ex-US companies — is a rarity but Junshi won one by chasing a malignancy that few other PD-1 developers had pursued. Nasopharyngeal carcinoma, one of a handful that can be triggered by Epstein-Barr virus, is most common in Southeast Asia and exceedingly rare in the US.
Novartis included it in studies that tested their checkpoint inhibitors on a range of solid tumors and the National Cancer Institute even ran a 45-person study testing Opdivo in the indication — finding a 20.5% response rate — but Junshi was one of only a couple companies to bring it into Phase III.
It was part of CEO Ning Li’s strategy to focus on rarer cancers, particularly ones that are somewhat more common in China. The company estimates there were about 129,000 new cases of the tumor in 2018. Although many patients have their cancers treated and cleared early, those diagnosed once the tumor has metastasized face a more difficult prognosis. Junshi estimates a 5-year survival rate of under 10% for those with advanced disease.
Junshi isn’t alone, though, in chasing the indication. Innovent and another Chinese drug developer, Jiangsu HengRui Medicine, have each put their PD-1s in Phase III studies for nasopharyngeal carcinoma and in the US, Merck has enrolled 233 patients in a trial they launched in 2015. It is scheduled to be completed later this year.