- AstraZeneca on Thursday said its medicines Tagrisso and Imfinzi each hit additional goals in Phase 3 trials in early lung cancer, building on earlier findings showing the drugs had succeeded in the two studies.
- In one announcement, AstraZeneca revealed its targeted cancer drug Tagrisso led to a “statistically significant and clinically meaningful” improvement in survival, compared to a placebo, among early-stage non-small cell lung cancer patients with a specific mutation to a gene called EGFR.
- In the other statement, the drugmaker disclosed a regimen involving Imfinzi and chemotherapy reduced the risk of disease progression or death, compared to chemotherapy alone, when administered both before and after surgery to remove a tumor. Details from both studies will be presented at a future medical meeting and, in Imfinzi’s case, shared with regulators.
While AstraZeneca previously reported both studies had hit their initial goals, the new updates are notable nonetheless.
Tagrisso’s results are another data point in a debate about whether a drug’s ability to stop tumors from returning is a suitable proxy for its ability to keep patients alive longer — the gold standard for a cancer medicine. These measures, known as “disease-free survival” or “event-free survival,” are widely used in early-stage disease tests. They’re meant to help speed medicines to market while accumulating evidence the drugs are also extending lives. But that hasn’t always been the case, stoking criticism of the endpoints from cancer doctors.
Tagrisso’s trial is the latest example. At the American Society of Clinical Oncology meeting in 2020, researchers reported patients who received Tagrisso were 79% less likely to have relapsed or have died than patients taking placebo. Oncologists interviewed by BioPharma Dive then called the data “unprecedented.” That’s now translated to what AstraZeneca described as a “strong” and “clinically meaningful” survival benefit, though it did not detail specific numbers.
“The key word in the title of the press release is strong,” wrote Stifel analyst Seb Wykeham in a note to clients. The findings could help boost sales of Tagrisso in a potentially lucrative market, he added. The drug generated $5.4 billion for AstraZeneca last year.
The Imfinzi study, meanwhile, represents another opportunity for lung cancer specialists to determine when an immunotherapy might be most effective for patients with early-stage tumors. Bristol Myers Squibb, Merck & Co., Roche and AstraZeneca have been testing slightly different regimens. While comparing drugs across trials can be difficult, Bristol Myers’ regimen — a nine-week course of chemotherapy and the immunotherapy Opdivo before surgery — led to the largest reduction in relapse risk reported so far. Merck’s and Roche’s studies, which had less pronounced benefits on that measure, involved longer regimens that began after surgery.
AstraZeneca tested a “perioperative” regimen, giving patients four treatment cycles of Imfinzi and chemotherapy prior to surgery and up to 12 of only Imfinzi afterwards. It previously hit one study goal, a measure of the regimen’s ability to wipe out tumors before surgery. AstraZeneca said it’s now led to a “statistically significant and clinically meaningful” improvement in event-free survival, the trial’s other primary objective. Without further details, it’s not clear how that benefit might compare to what’s been disclosed by its rivals.
Bristol Myers’, Merck’s and Roche’s drugs are already approved for use in early lung cancer. They haven’t been shown to extend patients’ lives yet.