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AstraZeneca Reports 16 Percent Q3 Oncology Sales Growth, Talks Up Future for TROP2 ADC


NEW YORK – AstraZeneca's oncology business saw steady gains with a 16 percent revenue increase during the third quarter of 2023, the drugmaker reported on Thursday morning.

For the three months ending Sept. 30, Cambridge, UK-based AstraZeneca brought in $4.39 billion in oncology product sales, up 16 percent versus the prior year's third quarter, or 17 percent at a constant exchange rate.

AstraZeneca's total revenues were $11.49 billion for the third quarter, up 5 percent from $10.98 billion in Q3 2022. The figure fell slightly short of analysts' average estimate of $11.66 billion for the quarter. Disregarding the negative impact of fallen sales of its COVID-19 vaccine, the firm said its total revenue increased 12 percent.

The firm brought in $1.47 billion in sales of its EGFR inhibitor Tagrisso (osimertinib), up 5 percent versus Q3 2023. In September, the firm reported that in the Phase III FLAURA2 trial, Tagrisso plus chemotherapy benefited advanced EGFR-mutated NSCLC patients versus Tagrisso alone, and the US Food and Drug Administration accordingly granted priority review to Tagrisso plus chemo in October. "We're well on our way to establishing Tagrisso at every stage for patients with EGFR-mutated non-small cell lung cancer," Dave Fredrickson, the executive VP of AstraZeneca's oncology business, said during a conference call to discuss the third-quarter financial results on Thursday.

Revenues for the HER2-directed antibody-drug conjugate Enhertu (trastuzumab deruxtecan), which AstraZeneca jointly markets with Daiichi Sankyo, climbed to $73 million in the third quarter of 2023, up more than 300 percent year over year. The drug recently netted approvals in Japan and the EU for advanced HER2-mutated NSCLC patients, and the firms are pursuing a tumor-agnostic approval for HER2-positive solid tumors in the US based on data from pan-tumor trials.

Sales of AstraZeneca's immune checkpoint inhibitor Imfinzi (durvalumab) increased 53 percent year over year, bringing in $1.13 billion in Q3 2023, and sales of Lynparza (olaparib), the PARP inhibitor that AstraZeneca markets together with Merck, brought in $702 million in revenues during Q3 2023, up 7 percent from the prior year's third quarter.

"Looking ahead, we're well positioned within our oncology portfolio," Fredrickson said. The firm's investigational TROP2-directed antibody-drug conjugate, Dato-DXd (datopotamab deruxtecan), which it is also codeveloping with Daiichi Sankyo, saw promising Phase III results as treatment for certain patients with HER2-low or HER2-negative breast cancer this past quarter. It also showed promise in NSCLC.

"These [studies] underscore its potential to replace backbone chemotherapy in these settings with both trials demonstrating the clear efficacy improvement of Dato-DXd versus conventional chemotherapy, together with an improved safety profile," said Susan Galbraith, the executive VP of oncology R&D. "Dato-DXd's best-in-class profile opens up future opportunities for combinations with both immunotherapy and platinum chemotherapy and builds confidence there is potential in earlier lines and other tumor types." According to Galbraith, the drugmaker is on its way to filing applications for Dato-DXd regulatory approvals for lung cancer and breast cancer.

AstraZeneca also has its eyes on entering the cell therapy space with three CAR T-cell therapies in development for solid cancers. The design is meant to resist patients' immunosuppressive tumor microenvironments, Galbraith said. One of these, the autologous GPC3-directed CAR T-cell therapy, C-CAR031, demonstrated potential in a first-in-human clinical trial in hepatocellular carcinoma.

For the third quarter of 2023, AstraZeneca posted net income of $1.38 billion, or $.89 per share, for the quarter compared to a net profit of $1.64 billion, or $1.06 per share, in Q3 2022. The 2023 quarterly earnings per share outperformed the average Wall Street estimate of $.84.

For full-year 2023, the firm is now expecting revenue growth in the mid-single digit percentage range at constant exchange rates. Previously, AstraZeneca projected low-to-mid single digits.