Capivasertib

AstraZeneca's TRUQAP (capivasertib) in combination with abiraterone and ADT showed significant improvement in radiographic progression-free survival (rPFS) in PTEN-deficient metastatic hormone-sensitive prostate cancer patients, with early trends towards overall survival (OS) improvement. Safety profile consistent with known profiles of each medicine, with notable risks of hyperglycemia, diarrhea, and cutaneous adverse reactions.

TRUQAP (capivasertib) + abiraterone + ADT significantly improves radiographic progression-free survival in PTEN-deficient metastatic hormone-sensitive prostate cancer patients, per CAPItello-281 Phase III trial.

The safety profile of Truqap in combination with abiraterone and ADT in CAPItello-281 aligns with known profiles of each medicine. Data will be presented at a medical meeting and shared with global regulatory authorities. CAPItello-281 is a Phase III trial evaluating Truqap's efficacy and safety in treating PTEN-deficient de novo mHSPC, with rPFS as the primary endpoint.

RLY-2608 plus fulvestrant showed clinically meaningful PFS and a favorable safety profile in heavily pretreated PI3Kα-mutated, HR+/HER2- breast cancer patients, with a median PFS of 9.2 months and an ORR of 33% in those with measurable disease.

Roche's PI3K inhibitor Itovebi approved by FDA for use in triple therapy for locally advanced or metastatic HR-positive, HER2-negative breast cancer with PIK3CA mutation. Phase 3 INAVO120 study showed progression-free survival more than doubled to 15 months with Itovebi compared to 7.3 months for control group. Roche predicts Itovebi sales could reach CHF 2 billion annually.

The TROPION-Breast01 phase III trial of datopotamab deruxtecan (Dato-DXd) did not achieve statistical significance in the final overall survival (OS) analysis for patients with inoperable or metastatic hormone receptor (HR)-positive, HER2-low or negative breast cancer. Despite this, the trial previously met the progression-free survival (PFS) endpoint, showing a significant improvement in PFS and patient-reported outcomes. The safety profile remained consistent with no new safety concerns. The treatment landscape's advancement with multiple antibody drug conjugates (ADCs) approved during the trial may have influenced the OS results.

TROPION-Breast01 Phase III trial of datopotamab deruxtecan did not achieve statistical significance in overall survival (OS) analysis for inoperable or metastatic HR-positive, HER2-low or negative breast cancer patients, despite meeting progression-free survival (PFS) primary endpoint. Safety profile consistent with previous analysis, with no new safety concerns. Multiple ADCs approved during trial likely affected survival results. AstraZeneca and Daiichi Sankyo continue discussions with regulatory authorities and clinical development for datopotamab deruxtecan.

Final overall survival results from TROPION-Breast01 Phase III trial of datopotamab deruxtecan (Dato-DXd) did not achieve statistical significance in HR-positive, HER2-low or negative breast cancer patients, despite positive progression-free survival results. Safety profile remained consistent with no new concerns. Subsequent treatment options likely affected survival results.

Warren Kotler, a 61-year-old man with Stage 4 metastatic breast cancer, has outlived his prognosis by receiving various treatments. His oncologist suggested a new drug, capivasertib (Truqap), which could delay cancer progression but is currently approved only for women in Canada due to insufficient male participation in clinical trials. Kotler's medical team seeks compassionate use of the drug, but AstraZeneca denies coverage, citing Health Canada's approval restrictions. Despite the drug's potential benefits and similar disease biology in men and women, regulatory bodies face challenges due to the rarity of male breast cancer cases.