KADCYLA side effects and safety profile

Adverse reactions (ARs) in KATHERINE were consistent with the known safety profile for KADCYLA1

Summary of ARs occurring in ≥10% of patients

*Included one fatal hemorrhage.

The most common Grade ≥3 ARs (>2%) were thrombocytopenia and hypertension.

The following clinically relevant ARs were reported in <10% of patients in the KADCYLA-treated group in KATHERINE: blood alkaline phosphatase increased (8%), dysgeusia (8%), dyspnea (8%), neutropenia (8%), blood bilirubin increased (7%), hypokalemia (7%), pruritus (7%), hypertension (6%), lacrimation increased (6%), chills (5%), dry eye (4.5%), dyspepsia (4.3%), peripheral edema (3.9%), vision blurred (3.9%), conjunctivitis (3.5%), left ventricular dysfunction (3.0%), drug hypersensitivity (2.7%), infusion-related reaction (1.6%), radiation pneumonitis (1.5%), pneumonitis (1.1%), rash (1.1%), asthenia (0.4%), nodular regenerative hyperplasia (0.3%).1

Understanding peripheral neuropathy in KATHERINE

  • In the KATHERINE trial, 32% of patients in the KADCYLA arm experienced any Grade peripheral neuropathy vs 17% in the Herceptin arm†1
  • 1.6% of patients in the KADCYLA arm experienced Grade ≥3 peripheral neuropathy vs 0.1% in the Herceptin arm1

70% of cases of peripheral neuropathy in the KADCYLA arm, including sensory and motor peripheral neuropathy, were resolved at the time of primary iDFS analysis1

  • An additional 9% of cases of peripheral neuropathy were resolving at the time of primary iDFS analysis3

These numbers differ from those noted in the AR table because a broader set of safety terms were included in this definition of neuropathy.1

Dosing for KADCYLA in EBC

See the efficacy results