CLINICAL NEWS

( PFS ) rate of 48 percent ( 95 % CI 43-52 ), according to results published in the Journal of Clinical Oncology .

While a 2013 report from this trial established that R-CHOP and R-FM were superior to R-CVP , with longer time to treatment failure ( TTF ) and higher rates of three-year PFS , the 2017 post-hoc analysis suggests that the more favorable toxicity profile associated with R-CHOP makes it the best immunochemotherapeutic option for this patient population .

“ With longer follow-up , we can conclude that if the aim of initial therapy is to maximize treatment activity and increase the chance of durable disease control , R-CHOP should be the preferred option among the three regimens ,” noted Stefano Luminari , MD , assistant professor of oncology at the University of Modena and Reggio Emilia in Italy , and co-authors . However , “ R-CVP might be seen as a good option for patients for whom the goal of therapy is treatment tolerability .”

The prospective , randomized , open-label , multicenter , phase III trial included previously untreated patients with advanced-stage symptomatic FL . Eligible patients had histologically confirmed grade 1 , 2 , or 3a FL ( according to the 2008 World Health Organization classification ); Ann Arbor stage II-IV disease ; and an Eastern Cooperative Oncology Group performance status score of 0-2 .

Patients with evidence of histologic transformation into aggressive lymphoma at diagnosis , central nervous system involvement , or a history of previous malignancy were excluded .

Between March 2006 and September 2010 , 534 patients were enrolled from 58 Italian institutions , then

GLOBAL PHASE 2 PIVOTAL TRIAL

Primary End Point : ORR at 3 Months 1 *

( N = 52 / 63 ) †

achieved remission ( CR / CRi )

10 0 % of patients in remission ( n = 52 ) were MRD – 1 ‡

• 96 % of responders ( n = 52 ) achieved remission between Days 26 and 31 , with a median time of 29 days 1

75 % of responders ( n = 52 ) estimated to still be in remission at 6 months 2

• Median duration of CR / CRi § was not yet reached at median follow-up of 4.8 months from response ( range : 1.2 to 14.1 + months ) 1

OVERALL SURVIVAL 2

PROBABILITY (%) OF EVENT FREE

100

80

60

40

20

• Median follow-up of 6.2 months ||

• OS was a secondary efficacy end point of the global phase 2 pivotal trial 3

• Median OS data are not in the label and should be interpreted with caution in a single-arm trial . The statistical significance of OS is not known

• Approximately 84 % ( 57 / 68 ) of patients were still alive ( censored ) at the data cut-off , and only 2 patients were at risk beyond 16 months

CR , complete remission ; CRi , complete remission with incomplete blood count recovery ; MRD –, minimal residual disease negative ; ORR , overall remission rate ; OS , overall survival .

* ORR consisted of CR and CRi ( defined as less than 5 % of blasts in the bone marrow , no evidence of extramedullary disease , and without full recovery of peripheral blood counts with or without blood transfusion ). Remission status was required to be maintained for at least 28 days without clinical evidence of relapse . 1

†

5 patients who were infused with KYMRIAH were excluded from the efficacy set . The efficacy analysis set ( N = 63 ) is a subset of the full analysis set which consists of all patients treated with KYMRIAH at least 3 months prior to data cut-off . 1 , 2

‡

MRD – was defined as MRD by flow cytometry < 0.01 %. 1

§

Duration of remission ( DOR ) was defined as time since onset of CR or CRi to relapse or death due to underlying cancer , whichever is earlier , censoring for new cancer therapy including stem cell transplant ( n = 52 ). 1

||

OS analysis was conducted on full analysis set ( n = 68 ). 2

WARNINGS AND PRECAUTIONS ( continued ) KYMRIAH REMS to Mitigate CRS and Neurological Toxicities : Because of the risk of CRS and neurological toxicities , KYMRIAH is available only through a restricted program under a Risk Evaluation and Mitigation Strategy ( REMS ) called the KYMRIAH REMS . Further information is available at www . kymriah-rems . com or 1-844-4KYMRIAH ( 1-844-459-6742 ).

References : 1 . Kymriah [ prescribing information ]. East Hanover , NJ : Novartis Pharmaceuticals Corp ; 2017 . 2 . Data on file . Study CTL019B . Novartis Pharmaceuticals Corp ; Feb 2017 . 3 . Data on file . Study CTL019B2202 . Novartis Pharmaceuticals Corp ; Sept 2017 .