Regeneron-Sanofi lung cancer drug study ends positively
Show Stopper
When a clinical trial ends early, it sounds like bad news. Nonetheless, Regeneron and Sanofi's cancer immunotherapy Libtayo has performed so well that the companies are ending the study early to pursue 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.
Libtayo, in concert with chemotherapy, kept patients with previously untreated advanced non-small cell lung cancer (NSCLC) alive for a median of 22 months, nine months longer than those who received platinum-doublet chemo alone in a pivotal Phase 3 trial of the drug, the companies said Thursday, as reported by Jonathan Gardner in BioPharma Dive. The companies will stop the study based on its independent data monitoring committee's recommendation after a prespecified interim analysis.
In February Libtayo entered the lung cancer market “when the FDA approved the PD-1 inhibitor as a monotherapy for patients with newly diagnosed, locally advanced or metastatic NSCLC whose tumors have high levels of PD-L1 expression,” according to Fraiser Kansteiner of Fierce BioPharma. The results released August 5 are from the Empower-Lung 3 study, which is also in first-line patients but those with any level of PD-L1 expression and combined Libtayo and chemotherapy.
The February approval put Libtayo into competition with Merck & Co.’s immunology superstar Keytruda. At the time SVB Leerink analyst Geoffrey Porges forecasted less than $1 billion in Libtayo peak sales in the disease, but he said that a future combination regimen might improve Libtayo's prospects. Since it was approved in first-line lung cancer in 2016, Keytruda has been a tough competitor. Bristol Myers Squibb has offered Opdivo, which failed in an early lung cancer study that held back its use in the tumor type. Because there are hundreds of thousands of cases diagnosed in the U.S. every year, non-small cell lung cancer is a huge market.
Competitors like Regeneron want to get market share away from Merck -- which had Keytruda sales of $4 billion last year -- and the new data might give the biotech company an opportunity. Treatment with the Libtayo-chemo combination reduced the risk of death by 29 percent compared to placebo. The Merck drug combined with chemotherapy is 51 percent, according to the Keytruda label.
Kennen MacKay, an analyst at RBC Capital Markets, said, "We anticipate these data will be seen as largely competitive vs. results from [Merck's] market-leading immuno-oncology drug Keytruda." However, Jack West, an oncologist at the City of Hope, criticized Regeneron's trial for using chemotherapy alone as a comparator. West also remarked that the inclusion of patients with Stage 3 cancer, or those whose tumors have not spread to other organs, may have biased the results of the trial.
Regeneron’s second quarter earnings, released on August 5, showed 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.
Still, investors were happy about sales from other leading Regeneron products like eye treatment Eylea, eczema drug Dupixent and COVID-19 antibody cocktail. All of those outperformed analysts' expectations, with Regeron's total quarterly sales of $5.1 billion greater than the consensus estimate of $4 billion, according to Piper Sandler analyst Christopher Raymond.