Eli Lilly's high hopes for Lartruvo hit the skids in January when the soft tissue sarcoma therapy flunked a phase 3 trial. Now that the failed drug is moving off the market, Lilly's trying to keep current patients on treatment.
Lilly has set up a program that would allow patients to continue on Lartruvo, but only after they've conferred with their doctors about its side effects and the phase 3 trial failure, the company said Thursday.
"Advanced soft tissue sarcoma is a rare and difficult-to-treat cancer," Lilly Oncology President Anne White said in a release. "Establishing this program will give patients who are currently taking Lartruvo the opportunity to continue their treatment program uninterrupted."
The program will only affect patients already on treatment when the drug was blacklisted for new prescriptions by U.S. and European regulators in late January, the company said.
Lartruvo’s late-stage flop came as a surprise after the drug's phase 2 results delivered green lights in the EU and U.S. But the phase 3 trial designed to confirm the earlier data, dubbed Announce, found the drug did not beat chemotherapy at helping patients live longer.
Lartruvo’s surprise failure has already hit Lilly's 2019 expectations. In February, the company said it would cut its sales and earnings guidance, citing the Lartruvo flop and costs associated with its $8 billion Loxo Oncology buy. Previously projecting revenues between $25.3 billion and $25.8 billion, Lilly dropped its revenue forecast to between $25.1 billion and $25.6 billion on the year. Adjusted earnings per share took an even bigger hit, dropping to $5.55 to $5.65 compared with the $5.90 to $6 range the company promised in December.
Lilly’s Loxo purchase did strengthen Lilly's oncology play; in that deal, the company nabbed TRK inhibitor Vitrakvi, the first FDA-approved drug to target tumors by genetic abnormality, as well as three other cancer prospects.
However, Bayer, which co-marketed Viktravi with Loxo, opted to take full control of the drug and an experimental TRK inhibitor in February, stripping Lilly's acquisition down to two unapproved treatments.
Meanwhile, Lilly has also had to contend with generic competition for its blockbuster erectile dysfunction drug Cialis and ADHD drug Strattera, which lost patent protection in 2018 and 2017, respectively.
In response, Lilly has leaned heavily on new launches, including diabetes drugs Jardiance and Trulicity, autoimmune meds Taltz and Olumiant and oncology drug Verzenio. Lilly is also in the early launch stages with Emgality, a new CGRP migraine med Lilly hopes can be the “treatment of choice” above rivals from Amgen and Teva.
Editor's Note: This story was updated to show that Bayer opted in February to take control of TRK inhibitor Viktravi and a separate experimental TRK inhibitor that were part of Eli Lilly's $8 billion buyout of Loxo Oncology.