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Key clinical point: Although all starting ponatinib doses showed clinical benefit among patients with resistant chronic-phase chronic myeloid leukemia (CML-CP), the optimal benefit-risk ratio was observed with 45 mg ponatinib reduced to 15 mg on achievement of a response.
Major finding: The response rates at 12 months in patients receiving 45 mg, 30 mg, or 15 mg ponatinib were 44.1% (98.3% CI 31.7%-57.0%), 29.0% (98.3% CI 18.4%-41.6%), and 23.1% (98.3% CI 13.4%-35.3%), respectively. Grade 3-5 treatment-emergent arterial occlusive events were observed in 5, 5, and 3 patients in the 45, 30, and 15 mg ponatinib cohorts, respectively.
Study details: The phase 2 OPTIC trial included 283 adult patients with CML-CP resistant/intolerant to at least 2 prior tyrosine kinase inhibitors or with T315l mutation, randomly assigned to receive a once-daily starting dose of 45 mg, 30 mg, or 15 mg ponatinib. Patients receiving 45 mg or 30 mg doses were reduced to 15 mg upon achievement of a response.
Disclosures: No source of funding was identified other than Millennium Pharmaceuticals, Inc. for medical writing assistance. Some investigators, including the lead author, reported ties with various pharmaceutical companies.
Source: Cortes J et al. Blood. 2021 Aug 18. doi: 10.1182/blood.2021012082.
Key clinical point: Although all starting ponatinib doses showed clinical benefit among patients with resistant chronic-phase chronic myeloid leukemia (CML-CP), the optimal benefit-risk ratio was observed with 45 mg ponatinib reduced to 15 mg on achievement of a response.
Major finding: The response rates at 12 months in patients receiving 45 mg, 30 mg, or 15 mg ponatinib were 44.1% (98.3% CI 31.7%-57.0%), 29.0% (98.3% CI 18.4%-41.6%), and 23.1% (98.3% CI 13.4%-35.3%), respectively. Grade 3-5 treatment-emergent arterial occlusive events were observed in 5, 5, and 3 patients in the 45, 30, and 15 mg ponatinib cohorts, respectively.
Study details: The phase 2 OPTIC trial included 283 adult patients with CML-CP resistant/intolerant to at least 2 prior tyrosine kinase inhibitors or with T315l mutation, randomly assigned to receive a once-daily starting dose of 45 mg, 30 mg, or 15 mg ponatinib. Patients receiving 45 mg or 30 mg doses were reduced to 15 mg upon achievement of a response.
Disclosures: No source of funding was identified other than Millennium Pharmaceuticals, Inc. for medical writing assistance. Some investigators, including the lead author, reported ties with various pharmaceutical companies.
Source: Cortes J et al. Blood. 2021 Aug 18. doi: 10.1182/blood.2021012082.
Key clinical point: Although all starting ponatinib doses showed clinical benefit among patients with resistant chronic-phase chronic myeloid leukemia (CML-CP), the optimal benefit-risk ratio was observed with 45 mg ponatinib reduced to 15 mg on achievement of a response.
Major finding: The response rates at 12 months in patients receiving 45 mg, 30 mg, or 15 mg ponatinib were 44.1% (98.3% CI 31.7%-57.0%), 29.0% (98.3% CI 18.4%-41.6%), and 23.1% (98.3% CI 13.4%-35.3%), respectively. Grade 3-5 treatment-emergent arterial occlusive events were observed in 5, 5, and 3 patients in the 45, 30, and 15 mg ponatinib cohorts, respectively.
Study details: The phase 2 OPTIC trial included 283 adult patients with CML-CP resistant/intolerant to at least 2 prior tyrosine kinase inhibitors or with T315l mutation, randomly assigned to receive a once-daily starting dose of 45 mg, 30 mg, or 15 mg ponatinib. Patients receiving 45 mg or 30 mg doses were reduced to 15 mg upon achievement of a response.
Disclosures: No source of funding was identified other than Millennium Pharmaceuticals, Inc. for medical writing assistance. Some investigators, including the lead author, reported ties with various pharmaceutical companies.
Source: Cortes J et al. Blood. 2021 Aug 18. doi: 10.1182/blood.2021012082.