SPRYCEL Chronic Phase Trial (100 mg)

Study Design

Open-label phase III trial in which 670 patients with imatinib-resistant or -intolerant chronic phase chronic myeloid leukaemia (CP-CML) were randomly assigned 1:1:1:1 between four dasatinib treatment groups: 100 mg once daily, 50 mg twice daily, 140 mg once daily, or 70 mg twice daily.

Primary Endpoint: The rate of MCyR in patients with imatinib resistance, with a minimum follow-up of 6 months.

SPRYCEL 100 mg QD: Efficacy

Prolong Survival in Chronic Phase CML with SPRYCEL 100 mg QD Dosing

For patients resistant or intolerant to imatinib, SPRYCEL provides:

Proven disease control

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Demonstrated survival

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Durability of response in imatinib-intolerant and -resistant patients

Efficacy in imatinib-intolerant chronic phase CML patients (2-year minimum follow-up)

In imatinib intolerant patients:

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Demonstrated Safety with SPRYCEL 100 mg Once Daily in Chronic Phase CML

The discontinuation rate for adverse drug reactions was lower for patients treated with 100 mg^† of SPRYCEL once daily than for those treated with 70 mg twice daily^* (8% and 15%, respectively).¹

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After a median duration of treatment of 22 months, patients with chronic phase CML receiving SPRYCEL 100 mg once daily^† experienced consistently lower rates of treatment-related adverse events compared to those in other treatment groups.

• The rate of discontinuation for adverse drug reactions was lower for patients treated with 100 mg QD than for those treated with 70 mg BID (8% and 15%, respectively)
• The rate of dose interruption and reduction were also lower for patients treated with 100 mg QD than for those treated with 70 mg BID
• Meyelosuppression was reported less frequently with the 100 mg once daily^† starting dose ^1,21
• The frequency of neutropenia, thrombocytopenia and anaemia was lower in the SPRYCEL 100 mg once daily group than in the SPRYCEL 70 mg twice daily group

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Comparable efficacy in QD and BID dosing and in the 100 mg and 140 mg total daily dose

• SPRYCEL demonstrated comparable efficacy with the once-daily schedule compared to the twice daily schedule
• Comparable efficacy was demonstrated between the 100 mg^† total daily dose and the 140 mg^† total daily dose (difference in MCyR –0.8%; 95% confidence interval [–9.6%–8.0%])

• ^*The dosage used in these studies is not recommended any longer for this patient population in the EU. The recommended starting dosage in the EU for chronic phase CML has been optimised to a 100 mg once daily regimen, reflecting a more favourable safety profile, with comparable efficacy.¹
• ^†This dosage might not be approved in your country. Please refer to your local prescribing information for specific indication.
• ^‡Includes conjunctival oedema, eye oedema, eye swelling, eyelid oedema, face oedema, gravitational oedema, localised oedema, oedema genital, oedema mouth, oedema peripheral, orbital oedema, periorbital oedema, pitting oedema, scrotal oedema, and swelling face.

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