Ribociclib

Palbociclib + standard therapy improved progression-free survival in hormone receptor–positive, HER2-positive metastatic breast cancer. No significant overall survival benefit observed among CDK4/6 inhibitor combinations in hormone receptor-positive/HER2-negative breast cancer. Patritumab deruxtecan showed similar efficacy to multiagent chemotherapy in high-risk hormone receptor-positive, HER2-negative breast cancer. Ciltacabtagene autoleucel achieved 100% complete response in high-risk smoldering multiple myeloma. Selinexor + ruxolitinib showed efficacy in myelofibrosis patients previously treated with ruxolitinib.

Pfizer's Ibrance showed efficacy in HR+, HER2+ metastatic breast cancer, extending median progression-free survival by 50% in Phase III PATINA trial. This marks the first benefit shown by a CDK4/6 inhibitor in this patient group, representing about 10% of breast cancers. Ibrance, first approved in 2015, generated $4.75 billion in 2023, while Novartis' Kisqali brought in $2.08 billion.

Experts discussed the NATALEE trial and adjuvant ribociclib in breast cancer at an FDA Special Session, emphasizing the need for further studies on dosing and benefits. The trial included 5,101 patients, with 43% completing three years of adjuvant Kisqali. The FDA approved Kisqali in 2024 for HR-positive, HER2-negative early breast cancer, with postmarketing commitments for diversity and overall survival analyses.

Kisqali (ribociclib) in combination with endocrine therapy showed a 28.5% reduction in distant recurrence in HR+/HER2- early breast cancer patients, with benefits extending beyond 3-year treatment. Data presented at SABCS reinforced the importance of adding CDK4/6 inhibitors to endocrine therapy for high-risk patients, regardless of nodal status.

Kisqali, a CDK4/6 inhibitor, shows promise in treating HR-positive, HER2-negative early breast cancer, as demonstrated by the NATALEE trial. The trial involved 5,101 patients, with Kisqali given for three years alongside an aromatase inhibitor. Despite its FDA approval in 2024, follow-up studies are ongoing to assess additional benefits, dosing strategies, and overall survival. The trial highlighted the need for more diverse patient representation and ongoing research into optimal treatment durations and doses.

Olema Oncology collaborates with Novartis for Phase III trial of palazestrant and Kisqali in ER+/HER2-negative metastatic breast cancer, funded by $250m private placement. Palazestrant, a CERAN and SERD, aims to improve outcomes in resistant cancers, with potential revenue of $855m by 2030.

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Roche to acquire Poseida Therapeutics for $1 billion. Merck, AstraZeneca, and Novartis see success in new drug studies. Novartis' Kisqali approved for broader breast cancer treatment in EU.