- Treatment with Regeneron and Sanofi's cancer immunotherapy Libtayo alongside chemotherapy kept patients with previously untreated lung cancer alive for a median of 22 months, nine months longer than those who received chemo alone in a Phase 3 trial of the drug, the companies said Thursday.
- Due to the drug's benefit, the study will be ended early. Regeneron and Sanofi said they would seek approval in the U.S. and Europe for first-line use of the drug in people whose cancer had spread throughout the lung and other parts of the body. If approved, Libtayo would compete with Merck & Co.'s Keytruda, which has become the preferred treatment of many physicians due to a similar lengthening of survival.
- The results weren't the only positive news Regeneron reported Thursday, as the company disclosed second quarter earnings that significantly surpassed Wall Street's expectations. Regeneron's eye treatment Eylea and its COVID-19 antibody drug in particular surprised analysts with stronger-than-expected sales.
Since its first approval in first-line lung cancer in 2016, Keytruda has proved a tough competitor for rival drugmakers to challenge with their own therapies. Bristol Myers Squibb has come the closest with its drug Opdivo, which notably failed in an early lung cancer study that held back its use in the tumor type and the company's ambitions for it for years.
But with hundreds of thousands of cases diagnosed in the U.S. every year, non-small cell lung cancer is a huge market, reflected in Keytruda's sales of $14 billion last year. Competitors like Regeneron aim to wrest market share away from Merck and the data the biotech released Thursday could give the biotech company a chance.
In February, Libtayo won Food and Drug Administration approval in lung cancer for patients whose tumors express a high level of a protein called PD-L1, which is correlated with response to immunotherapy. Thursday's announcement, by comparison, was from a trial called EMPOWER-Lung 3 that enrolled 466 patients regardless of their PD-L1 status. (Patients with biomarkers that made them eligible for other targeted treatments like Alecensa were excluded, however.)
Results, Regeneron said, showed treatment with the Libtayo-chemo combination reduced the risk of death by 29% compared to placebo. That's less than the 51% figure included on Keytruda's label when it's combined with chemotherapy, however, so Merck's drug might still be viewed favorably by physicians.
"We anticipate these data will be seen as largely competitive vs. results from [Merck's] market-leading immuno-oncology drug Keytruda," Kennen MacKay, an analyst at RBC Capital Markets, wrote in an Aug. 5 note to clients.
But Jack West, a City of Hope cancer doctor, criticized Regeneron's trial on Twitter for using chemotherapy alone as a comparator, calling it "unethical" to use a treatment that's now considered substandard. He also said the inclusion of patients with Stage 3 cancer, or those whose tumors haven't spread to other organs, may have biased the results of the trial.
The second quarter earnings released by Regeneron Thursday revealed how far behind Libtayo is in the cancer immunotherapy market. Sales totaled just $117 million for the three months ended June 30, versus Keytruda's $4.2 billion during that same period.
Investors appeared more pleased, however, by sales from other leading products like Eylea, eczema drug Dupixent and Regeneron's COVID-19 antibody cocktail. All of those outperformed analysts' expectations, with Regeron's total quarterly sales of $5.1 billion significantly exceeding the consensus estimate of $4 billion, Piper Sandler analyst Christopher Raymond wrote in an Aug. 5 note to clients.