Lilly oncology suffers another blow as Verzenio slapped with safety warning in Japan

Breast cancer therapy Verzenio was counted as one of the key growth drivers at Eli Lilly in the first quarter. But in Japan, where the company said it was seeing "nice uptake," the drug has run into a safety problem.

Japan’s health ministry on Friday warned of Verzenio’s potential side effect on the lungs after 14 patients taking the drug developed serious lung disease, the Japan Times reported. Of the 14 cases, at least four were suspected to have been caused by Verzenio, including one death case.

The drug, approved in the country last September, has been given to about 2,000 patients, Japan’s Ministry of Health, Labor and Welfare said, per the Japan Times. And according to Lilly Oncology chief Anne White on the company’s Q1 earnings call last month, the drug is enjoying "nice uptake" in Japan.

In Q1, Verzenio was credited as one of the key drivers of a 7% increase in product volume and 3% in sales. The drug’s $109 million haul roughly met analysts’ expectations and represents a 30% jump over the previous quarter. But that was benchmarked against a "surprisingly light" Q4 of $83 million, which missed estimates by $22 million, Credit Suisse analysts noted in February.

Lilly said it has updated the label for Verzenio in Japan to include a warning on the risk of interstitial lung disease (ILD), a group of disorders that causes scarring of lung tissue and hence breathlessness.

"ILD/pneumonitis is known to be more frequently observed in an East Asian population, and the majority of cases reported for Verzenio worldwide have been in Japan," Lilly said in a statement shared with FiercePharma. "The reason for higher incidence of noninfectious pneumonitis in this population is not fully understood, though differences in genetic sensitivity may play a role."

Verzenio faces in-class competition from Novartis’ Kisqali and Pfizer’s Ibrance. In clinical trials, it turned up high rates of diarrhea, which then-Bernstein (now Wolfe Research) analyst Tim Anderson said could dampen the drug’s uptake, while Lilly argued the diarrhea was very much manageable with loperamide, an over-the-counter therapy.

Meanwhile, Lilly is looking to pad Verzenio’s case with new data. Some of that will come from the Monarch 2 trial, on the back of which Verzenio won its initial FDA nod back in September 2017. The company is expecting to unveil in 2020 just how long the drug can extend the lives of patients with HR+/HER2- metastatic breast cancer, White said on the Q1 call. It is also counting on advancing the drug into earlier lines of therapy. The phase 3 MonarchE study is pitting Verzenio against standard endocrine therapy to see how it works to prevent tumor comeback, and it's expected to read out in 2021, according to White.

A safety ding for Verzenio would be another blow to Lilly’s ambitions in oncology. Soft tissue sarcoma therapy Lartruvo is already being taken off the market after flunking a phase 3 trial, forcing Lilly to dial down its 2019 revenue expectations in February.

Verzenio isn’t the only cancer drug that’s facing safety scrutiny in Japan, though. Earlier this month, the country’s health ministry ordered Bristol-Myers Squibb’s local collaborator, Ono Pharmaceutical to add a warning to megablockbuster Opdivo after a patient died of pituitary disorders following treatment with the PD-1 inhibitor.

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