Best-selling Tagrisso further outpaces an upcoming J&J rival, winning approval in new NSCLC indication
AstraZeneca’s flagship cancer drug is adding a new indication to its fleet.
Friday afternoon, the FDA granted Tagrisso the thumbs-up in non-small cell lung cancer for patients with EGFR mutations who had undergone tumor resection and optional, standard postoperative adjuvant chemotherapy. It’s another win for the drug as a prominent rival from J&J continues to play catch-up.
The drug, which is on pace to eclipse $4 billion in sales for 2020, had previously been approved in first line metastatic EGFR-mutated NSCLC and second-line metastatic NSCLC patients with EGFR T790M mutations.
Tagrisso’s new approval comes on the basis of a 682-person trial that was double-blinded, randomized and placebo-controlled. Patients were divided evenly into the drug and control arms, receiving either the 80 mg once-a-day pill or placebo, following surgery and chemo, if given.
Researchers were looking at disease-free survival in Stage II and Stage IIIa patients as the primary endpoint, and back in April they halted the study early due to “overwhelming efficacy.” The final result ended up being that median DFS was not reached, compared to 19.6 months in the control. Those figures clocked in at a p-value of p<0.0001.
DFS among all patients, a secondary endpoint, once again did not register a median figure. In the placebo arm, median DFS 27.5 months, good for another p-value of p<0.0001. There were no new safety concerns in the study.
The approval marks another notch in Tagrisso’s quiver as it continues to expand into the NSCLC market. EGFR mutations account for only about 10-15% of NSCLC patients in the US and Europe and 30-40% in Asia, per an AstraZeneca estimate, but it’s proven a successful endeavor for the drugmaker thus far.
Tagrisso continues to be AstraZeneca’s biggest seller, pulling in $3.17 billion through the first three quarters of this year. That total more than doubles any of its other oncology products such as Imfinzi ($1.49 billion) and Lynparza ($1.28 billion). Only Symbicort, the asthma and COPD drug, comes anywhere close to Tagrisso in total sales with just a hair over $2 billion in sales in the same time frame.
Friday’s news also gives Tagrisso a further leg up on J&J’s bispecific antibody amivantamab, which just a few weeks ago was submitted to the FDA for approval in EGFR-positive NSCLC. The Janssen-backed program is seeking to become the first medication greenlit for EGFR exon 20 insertion mutations. It’s an attempt to outflank Tagrisso, which thus far is approved to target exon 19 deletions or exon 21 L858R mutations.
Amivantamab is still playing from behind, however, and jumped straight from a Phase I study to a BLA after receiving breakthrough therapy designation. J&J has studied the candidate both as a monotherapy and in combination with an in-house TKI dubbed lazertinib.
Ultimately, J&J is expected to pit the amivantamab/lazertinib combo head-to-head with Tagrisso in the frontline setting for a Phase III trial.