It isn't the most common form of cancer, but tumors of the lung are so difficult to treat that they claim more lives than all others. This year at the 19th annual World Conference on Lung Cancer, Loxo Oncology Inc. (NASDAQ:LOXO), Roche Holding AG (OTC:RHHBY), and AstraZeneca PLC (NASDAQ:AZN) will present highly anticipated data for key lung cancer trials that could significantly alter how the disease is treated down the road.
Becoming a standard treatment for certain groups of patients can be worth billions in annual revenue. Here's what you need to know about presentations lined up that could give these stocks some lift near the end of September.
Loxo Oncology: Durable responses?
This stock shot up in response to positive data for a lung cancer candidate called LOXO-292 earlier this year and investors can't wait to find out more. Loxo showed us its first-in-class drug that specifically shuts down rearranged during transfection (RET) kinase activity shrank tumors for 22 of 32 patients with RET fusion-positive tumors earlier this year.
On Sept. 25, Loxo Oncology will present follow-up data from the mid-stage study with LOXO-292 that thrilled the crowd in June, and signs of durable responses would send the stock soaring further. Loxo thinks around 5,000 lung cancer patients who fail standard treatments each year have tumors that would respond strongly to LOXO-292.
Loxo Oncology's lead candidate, Larotrectinib, is in a pivotal study for a different group of lung cancer patients with a small population as well. The company intends to present signs of durable tumor responses to Larotrectinib at the same conference. The populations Loxo's drugs are aimed at may be small, but the dealmaking interest the company will receive if its first two attempts succeed could be huge.
Roche: A big deal for small cell patients
Drugs that take the brakes off the immune system so they can fight tumors have made a huge difference to people with non-small cell lung cancer (NSCLC), but options are limited for those with the aggressive small cell variety (SCLC) that accounts for 10% to 15% of all lung cancer cases.
In June, Roche let everyone know that adding its PD-L1 inhibitor, Tecentriq, to standard chemotherapy improved progression-free survival and overall survival for newly diagnosed SCLC patients. That's the first time any immunotherapy-based combination achieved both goals, but Roche is waiting for the World Conference on Lung Cancer to tell us how strong the benefit was.
Roche is keeping the results quiet until Sept. 25, and hopefully has a better reason for holding back than uninspiring data. Becoming a standard treatment for small cell lung cancer patients could quickly add more than $1 billion to Tecentriq sales that hit an annualized $657 million run rate in the first half of 2018.
AstraZeneca: Another niche winner?
This British pharma has an anti-PD-L1 drug of its own that is already approved to prevent stage 3 NSCLC from progressing after chemo and radiation therapy. Imfinzi became the first drug to earn approval for this indication in February and the sales are starting to roll in. Second-quarter Imfinzi sales were a surprising 97% higher than during the previous quarter. At an annualized run rate of just $488 million, though, this drug's still got a lot of room to grow in the important stage 3 maintenance therapy niche, because oncologists still aren't sure expensive Imfinzi treatment following chemoradiation actually gives their patients a better chance at long-term survival.
The FDA approved Imfinzi for the maintenance setting because a majority of those taking Imfinzi survived 16.8 months without signs of disease progression compared with just 5.6 months for those treated with chemoradiation alone. AstraZeneca's top line would get a big boost if the progression-free survival benefit that convinced the FDA to approve Imfinzi for this population turns out to provide a big overall survival benefit as well.
Pfizer (NYSE:PFE) investors will want to keep their eyes open for signs of life from another anti-PD-L1 drug partnered with Germany's Merck KGaA. Adding Bavencio to standard chemo failed to provide an overall survival benefit during the failed Javelin 200 study with second-line NSCLC patients.
Investigators pointed to some patients in the control group crossing over to drugs similar to Bavencio which may have made their drug seem less effective. If investigators make a strong case for this drug in second-line NSCLC, it could have a fighting chance to generate significant sales for the partners down the road.