Table 3.

Studies evaluating the outcomes generics in the frontline setting

AuthorsCountrySample size, nMedian follow-up duration (mo)Cumulative CCyR rates (%)Cumulative MMR rates (%)Adverse events (≥grade 3) (%)Results and commentsName of generic and/or manufacturer
Branded IMGenericsPBranded IMGenericsPBranded IMGenerics
Eskazan et al, 2014,40  Turkey Generics: 26; Branded IM: 36 Generic arm: 8.5; Branded IM arm: 20 56 52 .818 33 33 1 NR NR Rates of switching to second generation TKIs due to resistance and dose reduction because of AEs were comparable NA 
Chikkodi et al, 2015,31  India Generics: 28; Branded IM: 103 12 for both arms NA NA NA NR NR NR NR NR No significant differences were observed at CHR or molecular responses at 3, 6, and 12 mo of therapy between arms NA 
Eskazan et al, 2017,28  Turkey Generics: 43; Branded IM: 47 Generic arm: 13; Branded IM arm: 32.5 93 83 .25 89 59 .009 NR NR Comparable EMR rates at 3 mo, OR rates at 6 mo; however, MMR rate at 6 mo is superior in branded IM arm NA 
Entasoltan et al, 2017,29  Algeria Generics: 355 46 NA NR NA NA 67 NA NA 27* Similar efficacy and safety profile comparing IRIS trial Imatib (Cipla) 
Danthala et al, 2017,26  India Generics: 144; Branded IM: 1067 ∼46 for both arms 70 69 NR 23 15 NR 0 0 Comparable CCyR, MMR, DMR, EFS, FFS, TFS, OS and adherence rates between arms Veenat (Natco) 
Nekoohesh et al, 2020,30  Iran Generics: 177 34.8 NA NR NA NA 61 NA NA NR Lower MMR rates at 6 and 12 mo of generic imatinib comparing IRIS data (25.2% vs 33.3% and 44.2% vs 50.3%, respectively, P = not reported) NA 
Phukan et al, 2020,32  India Generics: 76 12 NA 52 NA NA 44 NA NA 28.9† 44.7% and 41.3% of patients achieved optimal response at 6 and 12 mo of therapy, respectively NA 
Dou et al, 2020,27  China Generics: 210; Branded IM: 238 Generic arm: 30; Branded IM arm: 34 88.8 89.4 .782 72.8 64.8 .138 8.3 7.7 4-y probabilities of achieving CCyR for branded and generic imatinib: 97.0% vs 97.3%; P = .736, MMR: 87.8% vs 90.1%; P = .113, respectively Xinwei (Hansoh); genike (Chiatai Tianqing) 
AuthorsCountrySample size, nMedian follow-up duration (mo)Cumulative CCyR rates (%)Cumulative MMR rates (%)Adverse events (≥grade 3) (%)Results and commentsName of generic and/or manufacturer
Branded IMGenericsPBranded IMGenericsPBranded IMGenerics
Eskazan et al, 2014,40  Turkey Generics: 26; Branded IM: 36 Generic arm: 8.5; Branded IM arm: 20 56 52 .818 33 33 1 NR NR Rates of switching to second generation TKIs due to resistance and dose reduction because of AEs were comparable NA 
Chikkodi et al, 2015,31  India Generics: 28; Branded IM: 103 12 for both arms NA NA NA NR NR NR NR NR No significant differences were observed at CHR or molecular responses at 3, 6, and 12 mo of therapy between arms NA 
Eskazan et al, 2017,28  Turkey Generics: 43; Branded IM: 47 Generic arm: 13; Branded IM arm: 32.5 93 83 .25 89 59 .009 NR NR Comparable EMR rates at 3 mo, OR rates at 6 mo; however, MMR rate at 6 mo is superior in branded IM arm NA 
Entasoltan et al, 2017,29  Algeria Generics: 355 46 NA NR NA NA 67 NA NA 27* Similar efficacy and safety profile comparing IRIS trial Imatib (Cipla) 
Danthala et al, 2017,26  India Generics: 144; Branded IM: 1067 ∼46 for both arms 70 69 NR 23 15 NR 0 0 Comparable CCyR, MMR, DMR, EFS, FFS, TFS, OS and adherence rates between arms Veenat (Natco) 
Nekoohesh et al, 2020,30  Iran Generics: 177 34.8 NA NR NA NA 61 NA NA NR Lower MMR rates at 6 and 12 mo of generic imatinib comparing IRIS data (25.2% vs 33.3% and 44.2% vs 50.3%, respectively, P = not reported) NA 
Phukan et al, 2020,32  India Generics: 76 12 NA 52 NA NA 44 NA NA 28.9† 44.7% and 41.3% of patients achieved optimal response at 6 and 12 mo of therapy, respectively NA 
Dou et al, 2020,27  China Generics: 210; Branded IM: 238 Generic arm: 30; Branded IM arm: 34 88.8 89.4 .782 72.8 64.8 .138 8.3 7.7 4-y probabilities of achieving CCyR for branded and generic imatinib: 97.0% vs 97.3%; P = .736, MMR: 87.8% vs 90.1%; P = .113, respectively Xinwei (Hansoh); genike (Chiatai Tianqing) 

NA, not available; NR, not reported; TFS, transformation-free survival.

*

Highest grade 3 to 4 AE rate (bone and joint pain). Cumulative rate of grade 3 and 4 AEs was not reported.

†

Highest grade 3 to 4 AE rate (anemia). Cumulative rate of grade 3 to 4 AEs was not reported.

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