AstraZeneca has come up short in another phase 3 trial of the AKT inhibitor Truqap, raising more questions about the blockbuster potential of the first-in-class cancer treatment.
Alongside its first-quarter earnings report, AZ revealed that an interim analysis of a study investigating Truqap in metastatic castration-resistant prostate cancer showed it was unlikely to meet the dual primary endpoints of progression-free survival and overall survival.
The CAPItello-280 trial was evaluating Truqap added to androgen-deprivation therapy (ADT) and the chemotherapy docetaxel, comparing the combination’s performance to ADT plus docetaxel.
It is the second phase 3 trial flop for highly touted Truqap, which was approved in November of 2023 in a narrow group of HR-positive, HER2-negative breast cancers with certain genetic alterations. In the CAPItello-290 study, which evaluated Truqap in triple-negative breast cancer, it failed to move the needle when added to the chemotherapy paclitaxel.
In a conference call Tuesday with reporters, AZ CEO Pascal Soriot reiterated the company’s projection that Truqap can achieve between $1 billion and $3 billion in annual sales.
“We still believe that we can be in that range,” Soriot said. “Of course, having missed on this prostate study, the potential will be smaller.”
The CAPItello-280 setting was a bit risky, he added.
Meanwhile, the phase 3 CAPItello-281 trial evaluating Truqap in de novo PTEN-deficient metastatic hormone-sensitive prostate cancer remains ongoing to assess overall survival data after the primary endpoint of progression-free survival was met last year.
AZ’s first disappointment with Truqap came with its FDA nod, which was for a smaller patient population than the company had hoped because of a biomarker stipulation.
Truqap was off to a decent start, reaching $430 million in 2024 sales in its first full year on the market. However, its $132 million haul in the first quarter of this year was down sequentially from $163 million and came 17% below analysts’ expectations.
Elsewhere, with the looming Trump administration tariffs on pharmaceuticals, AZ said that it has begun to move production of some drugs from Europe to the U.S. Chief financial officer Aradhana Sarin added that AZ has a built-in “dual-source supply” capability and can increase capacity of its U.S.-based facilities when needed.
“The incremental investment for that to happen will be manageable,” Sarin said.
AZ reported a 7% year-over-year revenue increase in the first quarter to $13.6 billion and reiterated its guidance to achieve a high single-digit increase in sales in 2025, coming off a year in which its revenue increased by 18%.