After notching a win in early-stage lung cancer in March, AstraZeneca’s top-selling med Tagrisso has turned out another triumph in the clinic, this time with some help.
Tagrisso plus chemotherapy helped patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) live longer without their disease worsening compared with Tagrisso alone, the company said Wednesday.
While Tagrisso alone already represents a global standard of care for EGFRm NSCLC, the med’s win in tandem with chemotherapy in AZ’s phase 3 FLAURA2 trial suggests a combo regimen could further improve treatment standards.
“These significant FLAURA2 results show TAGRISSO has the potential to offer patients in the first-line setting a new treatment option that can extend the time they live without their disease progressing,” Susan Galbraith, Ph.D., executive vice president of oncology R&D at AstraZeneca, said in a statement.
AZ says it will present the new Tagrisso data at an upcoming medical meeting and share the results with regulators around the world.
The overall survival data—the gold standard for oncology meds—were immature at the time of AZ’s analysis and will be presented at a future date, the company added.
NSCLC is the most common form of lung cancer, affecting some 80% to 85% of 2.2 million diagnosed with lung cancer globally each year, AZ pointed out. About 10% to 15% of patients in the U.S. and Europe, and 30% to 40% of patients in Asia, have EGFRm NSCLC.
The clinical victory comes shortly after Tagrisso showed it can significantly extend patients’ lives against placebo in the adjuvant treatment of stage 1B to 3A EGFRm NSCLC after complete tumor resection.
Those results came from the phase 3 ADAURA trial, which helped Tagrisso clinch an approval in late 2020 for adjuvant treatment of NSCLC.
Meanwhile, AZ is also trying to move Tagrisso into even earlier NSCLC treatment. As part of that effort, the ADAURA2 trial is testing adjuvant Tagrisso in stage 1A2 and 1A3 cancer, while the NeoADAURA study is weighing the med as a neoadjuvant therapy.
AZ also plans to share results on Tagrisso from the phase 3 LAURA trial in unresectable stage 3 NSCLC in the second half of 2023. LAURA is assessing Tagrisso as a maintenance treatment for stage 3 patients after response to initial chemoradiation therapy. This could help the drug clinch an approval to match its sibling Imfinzi in stage 3 NSCLC, albeit in EGFR-driven disease.
Tagrisso is AZ’s top-selling product. The EGFR lung cancer med pulled down about $5.4 billion in 2022 sales.
In a recent interview with Fierce Pharma, AZ’s CEO Pascal Soriot touted AZ’s cancer experts as “the best oncology team in the industry,” though he noted that wasn’t always the case. When he took over the company in 2012, “we had only a handful of people who understood oncology well,” the CEO said.
Soriot described AZ’s oncology pivot as the “best, the most important, the most remarkable change” at the company over the last eight to 10 years.