NEW YORK – AstraZeneca on Thursday said it plans to invest broadly in developing new lung cancer treatments, particularly immuno-oncology and biomarker-driven drugs.
AstraZeneca executives discussed these plans during a call on the company's financial performance in Q1 2023, during which period the firm's total revenue dipped 4 percent to $10.88 billion compared to Q1 2022, though flat at constant exchange rates. On average, analysts were expecting $10.55 billion.
Oncology products contributed $4.15 billion in revenue in Q1 2023, increasing 19 percent at CER over the year-ago period. The company is hoping to continue the momentum in the segment by expanding its footprint in cancer, according to Dave Fredrickson, head of AstraZeneca's oncology business. "For the first time, we're laying out our ambition in lung cancer," Fredrickson said during the call. "By the year 2030, we are aiming for at least half of all lung cancer patients to be eligible for an AstraZeneca medicine."
AstraZeneca is planning to focus initially on treatments for late-stage non-small cell lung cancer, building on the success of Tagrisso (osimertinib) as the established standard-of-care therapy in adjuvant and first-line settings for EGFR-mutated NSCLC. Tagrisso, the top-selling oncology drug in AstraZeneca's oncology portfolio, recorded sales of $1.42 billion in Q1 2023, a 9 percent increase (15 percent at constant exchange rates) compared to the same period in 2022.
Fredrickson said there was sustained demand for Tagrisso in the US in Q1, though 8 percent revenue growth in Europe was offset by pricing clawbacks in some markets. Tagrisso sales also grew 17 percent in emerging markets, including China.
Data presented at the American Association for Cancer Research's annual meeting showed a "strong" overall survival benefit with adjuvant Tagrisso treatment among early-stage patients compared to those on placebo, Susan Galbraith, AstraZeneca executive VP of oncology R&D, said.
"We're looking to solidify [Tagrisso's] position as the backbone [tyrosine kinase inhibitor] therapy in the EGFR-mutated space through additional combination trials," Fredrickson said.
He added that the firm hopes to also accelerate development of its "next wave" immuno-oncology assets. AstraZeneca will leverage its experience with the immunotherapy Imfinzi (durvalumab) across multiple tumor types, he said, and advance its HER2-targeted antibody-drug conjugate portfolio, which contains the TROP2-targeted ADC datopotamab deruxtecan (Dato-DXd).
"Underpinning this roadmap is also continued investment behind new technologies, including screening and testing tools, as well as innovative platforms such as new cell therapies," Fredrickson said.
Meanwhile, during Q1 AstraZeneca's other precision oncology drugs also performed well. The HER2-targeted breast cancer therapy Enhertu (trastuzumab deruxtecan), which AstraZeneca markets with Daiichi Sankyo, recorded sales of $37 million in Q1 2023, more than three times its sales in the year-ago period. Fredrickson said the drug has 50 percent of the new patient market in the second-line HER2-positive and hormone receptor-positive HER2-low metastatic breast cancer settings, "reflecting the strength of our underlying clinical data."
The US Food and Drug Administration approved Enhertu in May 2022 as a second-line therapy for patients with unresectable or metastatic HER2-positive breast cancer based on results from the DESTINY-Breast03 Phase III trial, in which treatment with Enhertu reduced the risk of disease progression or death by 72 percent compared to Genentech's Kadcyla (trastuzumab emtansine). Subsequent approvals followed in Europe in July 2022 and China in February 2023.
Q1 2023 sales of the PARP inhibitor Lynparza (olaparib) increased 5 percent (10 percent at CER) to $651 million and sales of Imfinzi increased by 50 percent (56 percent at CER) to $900 million compared to the year-ago quarter.
Lynparza is approved in the US for the treatment of BRCA1/2-mutated advanced ovarian cancer; early HER2-negative breast cancer; metastatic pancreatic cancer; and metastatic castration-resistant prostate cancer (mCRPC) harboring homologous recombination repair deficiency. Sales of the drug grew 18 percent in Europe, particularly following its launch in Germany as a first-line therapy for mCRPC.
"While there are opportunities for continued expansion in the US, these growth areas are more challenging," Fredrickson said. "Specifically, we continue to work on improving [homologous recombination deficiency] testing rates in ovarian [cancer] as well as BRCA testing and prescribing rates in hormone receptor-positive breast cancer."
Fredrickson said that Imfinzi's "impressive" sales growth was driven by uptake in new indications in first-line advanced biliary tract cancer and hepatocellular carcinoma.
Looking ahead, the company plans to present results from several precision oncology trials at the American Society of Clinical Oncology's annual meeting in June, including the DESTINY-PanTumor02 Phase II trial of Enhertu in heavily pretreated patients with HER2-expressing advanced solid tumors. The company reported in March that this trial met its prespecified target for objective response rate and demonstrated durable responses.
"Obviously, this is something we're going to need to discuss with regulatory authorities and there'll be a question about the appropriate biomarker cutoff across different indications," Galbraith said in reference to Enhertu's potential as a pan-tumor drug. She also noted that there's an overlap between HER2-mutant disease and HER2 overexpression, since HER2-mutant tumors are often highly overexpressing.
In Q1 2023, AstraZeneca posted net income of $1.80 billion, or $1.16 per share, compared to a net profit of $388 million, or $.25 per share, in Q1 2022. The consensus Wall Street EPS estimate was $1.07.
The firm finished the quarter with $6.46 billion in cash and investments.