NEW YORK – AstraZeneca reported on Thursday morning that revenues from its oncology products in the third quarter of 2022 increased 20 percent compared to the same period last year led by precision cancer treatments Tagrisso (osimertinib), Lynparza (olaparib), and Imfinzi (durvalumab).
All three drugs racked up solid double-digit sales growth in Q3 2022 compared to Q3 2021. The EGFR inhibitor Tagrisso's sales increased 12 percent to $1.40 billion; the PARP inhibitor Lynparza's sales increased 12 percent to $659 million; and the immunotherapy Imfinzi's sales increased 19 percent to $737 million.
The HER2-targeted drug Enhertu (trastuzumab deruxtecan), which AstraZeneca markets with Daiichi Sankyo, recorded revenues of $23 million in Q3 2022, more than four times the sales in the year-ago period.
Overall, the company reported $10.98 billion in revenues in Q3 2022, an increase of 11 percent over Q3 2021. AstraZeneca's oncology products contributed $4.04 billion to total revenues. On average, analysts had expected total revenues of $10.91 billion.
During a call to discuss the company's financial performance, AstraZeneca's executive team provided an update on AstraZeneca's oncology portfolio. Dave Fredrickson, head of AstraZeneca's oncology business, addressed the relatively slow uptake of Tagrisso in the adjuvant setting in NSCLC, for which it was approved by the US Food and Drug Association in 2021. "It's been a much longer educational process than what we were able to do in metastatic" NSCLC, he said. "In large part, it's because we're really trying to change behaviors."
He noted that 18 to 24 months ago, many lung cancer patients were not receiving adjuvant therapy at all because of a belief among physicians that surgery alone is sufficient. "We've been effectively making inroads against that, along with ensuring that patients undergoing surgery in those early stages of disease are referred to multidisciplinary teams and medical oncologists so that they can receive therapy," Fredrickson said. "It's a slower process that will ultimately pay off in terms of patient outcomes and in terms of duration of therapy."
"The biggest issue is really screening and diagnosing patients early in lung cancer, which is a big problem compared to breast cancer, for instance," added AstraZeneca CEO Pascal Soriot during the call.
Two precision oncology assets AstraZeneca is focused on developing are the selective estrogen receptor disruptor (SERD) camizestrant and the TROP2 inhibitor Dato-DXd. In October, the firm reported data from the SERENA-2 Phase II trial of camizestrant in post-menopausal patients with ER-positive locally advanced or metastatic breast cancer who had been previously treated with endocrine therapy. In the trial, camizestrant demonstrated a significant improvement in progression-free survival compared to fulvestrant.
Susan Galbraith, AstraZeneca's head of oncology R&D, said the company is planning to present additional data at the San Antonio Breast Cancer Symposium next month, but she tried to manage expectations by adding that SERENA-2 was designed as a randomized dose-finding study. "The setting of second-line, endocrine-sensitive breast cancer isn't one where monotherapy endocrine therapy is perhaps the best opportunity to make the biggest difference for patients," Galbraith said.
Recent clinical studies of SERDs in patients with ER-positive breast cancer, particularly the Phase III EMERALD trial of Menarini Group's elacestrant, have suggested that much of the benefit of SERDs are attributable to patients with ESR1 mutations. AstraZeneca does not plan to disclose any subgroup results for SERENA-2 ahead of the meeting, but Galbraith said, "we're confident that the role of this [therapy] is not just in ESR1 patients but also in the endocrine sensitive population beyond ESR1-mutated patients."
In an update on the progress of its antibody-drug conjugate Dato-DXd, Galbraith said AstraZeneca will use Trop2 levels to select patients for its TROPION-Lung07 trial in first-line, non-squamous advanced or metastatic NSCLC. In that study, about 975 patients whose tumors express Trop2 and have less than 50 percent tumor PD-L1 expression will be randomized to Dato-DXd plus pembrolizumab plus platinum chemotherapy or Dato-DXd plus pembrolizumab, or pembrolizumab plus pemetrexed plus platinum chemo. The primary outcome measures will be progression-free survival and overall survival.
"It's important that you get the right immunohistochemistry assay for [Trop2] and understand the cutoffs," Galbraith said, adding that AstraZeneca is considering using computational pathology, among other techniques. She noted that Trop2 expression will be important in terms of identifying the right patient population across a number of different potential indications for Dato-DXd, but based on results from the TROPION-Lung01 study, "we're very confident based on the data that we've already seen from Phase I that we can beat the current standard of care in an all-comers patient population."
For Q3, AstraZeneca posted a net profit of $1.64 billion, or $1.06 per share, compared to a net loss of $1.65 billion, or $1.10 per share, in Q3 2021.
The firm finished the quarter with $4.46 billion in cash and cash equivalents.