AstraZeneca's Tagrisso, Imfinzi have been slowed by COVID-19, but growth is coming: exec

AstraZeneca's COVID-19 vaccine may be getting all the headlines these days, but oncology is still the company’s core business. While AZ's two top-selling cancer drugs showed signs of slowing down, that’s only momentarily, an exec said.

EGFR inhibitor Tagrisso brought in sales of $1.15 billion in the first quarter, while PD-L1 inhibitor Imfinzi racked up $556 million. Both performances marked double-digit growths over the same period last year, but they were roughly flat over the prior quarter and came in below industry watchers’ expectations.

Both drugs draw the majority of their sales—if not entirely—from non-small cell lung cancer. A 20% to 30% reduction in the number of new patient diagnoses as a result of the pandemic hurt the business, Dave Fredrickson, AstraZeneca’s oncology business chief, explained in an interview.

Tagrisso in late December won a key U.S. nod that allows it to treat early EGFR-mutant NSCLC after surgery. That new use obviously hasn’t played out in sales numbers.

In that setting, Tagrisso faces a two-fold challenge, Fredrickson noted. Early-stage NSCLC represents about a quarter of the overall patient population with metastatic disease, for which Tagrisso was originally approved. Today, only half of NSCLC patients are actually tested for an EGFR mutation that would decide whether they’re eligible for Tagrisso.

What’s more, only a quarter of all stage IB to stage IIIA patients are receiving the so-called adjuvant therapy post-surgery because there’s a question about whether current standard chemotherapy is providing enough survival benefit, he said.

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Meanwhile, AZ is making good progress in terms of driving diagnosis and pushing for more adjuvant treatment with Tagrisso’s clinical data, Fredrickson said. AZ could see some uptick in new patient starts, but the “real value” of the adjuvant use will only manifest in about two to three years. At that time, the drug will show a “compounding effect” from adding and retaining patients, he said.

For Imfinzi, AZ recently withdrew the drug’s original second-line bladder cancer indication in the U.S. after a confirmatory trial flop. Fredrickson described that nod as “a fast-to-market opportunity” to get Imfinzi on doctors’ radar. It was the fifth entrant in that field, and its sales there were “negligible” compared with its mainstay NSCLC use.

Looking forward, several other Imfinzi bladder cancer trials are set to read out in the next year or so, the exec said.

“Really the future for Imfinzi in bladder cancer is going to be determined by the next set of the three to four readouts much more so than what's happened with the second line,” he said.

Elsewhere in AZ’s oncology portfolio, the Merck-shared PARP inhibitor Lynparza posted a year-over-year sales increase of 33% at constant exchange rates to $543 million. It’s also heading for a potential adjuvant use with a recent positive phase 3 readout showing it could prevent invasive disease or death for patients with BRCA-mutated, high-risk, HER2-negative early breast cancer.

About 80% of breast cancer is HER2-negative, and within that population, about 7% to 8% are BRCA-mutated, Fredrickson said. A large number of cases are caught at the early stage, he said.

RELATED: AstraZeneca's already dominant Lynparza lines up for early breast cancer with new trial win

An approval in early disease could help Lynparza better fend off competition from GlaxoSmithKline’s rival PARP inhibitor Zejula.

In ovarian cancer, the two drugs entered the so-called first-line maintenance setting for women who’ve responded to an initial round of chemo. While both meds are allowed for those with or without BRCA mutations, Zejula has a leg up with FDA clearance to treat patients with HRD-negative tumors, who make up about half of the total patient population.

Lynparza is on “parity” with Zejula in terms of new patients starts in ovarian cancer, and it’s the “clear leader” in the HRD-positive group, to which Lynparza’s limited, Fredrickson said.

Together, sales for AZ’s oncology business climbed 15% at constant exchange rates to $2.98 billion during the first quarter. The British pharma’s total revenue during the quarter hit $7.32 billion, including $275 million from its COVID-19 vaccine.