NEW YORK – AstraZeneca's launch of the AKT inhibitor Truqap (capivasertib) for breast cancer continues to gain momentum despite a Phase III failure in triple-negative disease last month, executives said Thursday during a call to discuss the company's second quarter financials.
The US Food and Drug Administration approved Truqap as a treatment for patients with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancers bearing alterations in PIK3CA, AKT1, or PTEN in November 2023. The agency based that decision on results from the Phase III CAPItello-291 trial, in which treatment with Truqap and fulvestrant reduced the risk of disease progression or death by 50 percent compared to fulvestrant alone in 289 patients with PICK3CA/AKT1/PTEN-altered tumors. At the same time, the FDA also approved the FoundationOne CDx assay as a companion diagnostic to identify breast cancer patients likely to benefit from Truqap and fulvestrant.
The drugmaker reported $92 million in second quarter revenues for Truqap. During the call, AstraZeneca Executive VP David Fredrickson said those numbers reflect "strong adoption in the biomarker-altered population," as well as "impressive" adoption of biomarker testing with the FoundationOne CDx assay.
Truqap did not fare as well in a study of patients with triple-negative breast cancer. In the Phase III CAPItello-290 trial, AstraZeneca tested Truqap and paclitaxel as a first-line treatment for over 900 patients with advanced triple-negative breast cancer compared to placebo and paclitaxel including a subgroup of patients with PIK3CA, AKT1, and PTEN alterations. That trial failed to demonstrate an improvement in overall survival in patients with advanced or metastatic triple-negative breast cancer, either in the overall population or in the biomarker-defined subgroups.
"It was disappointing that we didn't meet the primary endpoint in the triple-negative breast cancer setting," said AstraZeneca Executive VP of Oncology R&D Susan Galbraith. However, she explained that might be due to an interaction between AKT pathway and endocrine signaling in breast cancer, which may also apply to the CAPItello-281 trial of Truqap plus abiraterone in patients with PTEN-deficient, metastatic hormone-sensitive prostate cancer. "In both [breast and prostate cancer] settings, there's a reciprocal relationship between endocrine signaling [and AKT signaling]," Galbraith said. "One of the things that gives us confidence in the [prostate cancer] indication is the data we've seen from CAPItello-291 in endocrine sensitive breast cancer."
AstraZeneca executives also discussed the company's overall Q2 financial performance on the call, as well as additional oncology product revenues. For the three months ending June 30, the firm's total revenue was $12.94 billion, a 13 percent increase from $11.42 billion in Q2 2023, exceeding analysts' average revenue estimate of $12.63 billion. At constant exchange rates, the firm's total revenue increased 17 percent during this period.
Oncology products contributed $5.33 billion to AstraZeneca's Q2 revenues, increasing 15 percent compared to the year-ago period.
Tagrisso (osimertinib), an EGFR inhibitor and AstraZeneca's top-selling cancer drug, recorded $1.61 billion in sales in Q2, an 8 percent increase compared to the same period in 2023.
The HER2-targeted breast cancer therapy Enhertu (trastuzumab deruxtecan), which AstraZeneca markets with Daiichi Sankyo, brought in $472 million in Q2, an increase of 46 percent over the year-ago period.
In the second quarter, sales of the PARP inhibitor Lynparza (olaparib) increased to $744 million, a 4 percent increase compared to Q2 2023. AstraZeneca markets Lynparza with Merck in several tumor types characterized by mutations in BRCA1/2 and other homologous recombination repair genes. Over this same period, sales of AstraZeneca's PD-L1 inhibitor Imfinzi (durvalumab) increased by 13 percent to $1.15 billion.
In Q2 2024, AstraZeneca posted a net profit of $1.93 billion, or $1.24 per share, compared to a net profit of $1.82 billion, or $1.17 per share, in Q2 2023. The consensus Wall Street EPS estimate was $1.20.
As of June 30, AstraZeneca had $7.08 billion in cash and investments.
The company increased its guidance for 2024 with total revenue and core EPS expected to grow by a mid-teens percentage at constant exchange rates. It had previously guided a low double-digit to low-teens percentage increase.