Bendamustine with rituximab for the first-line treatment of advanced indolent non-hodgkin's and mantle cell lymphoma

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1 LONDON CANCER NEW DRUGS GROUP RAPID REVIEW Bendamustine with rituximab for the first-line treatment of advanced indolent non-hodgkin's and mantle cell lymphoma Bendamustine with rituximab for the first-line treatment of advanced indolent non-hodgkin's and mantle cell lymphoma Contents Summary 1 Background 2 Epidemiology 3 Cost 4 References 6 Summary The combination of bendamustine and rituximab (BR) is not currently licensed for the first-line treatment of indolent NHL and mantle cell lymphoma (MCL); however a submission to the European Medicines Agency has been made and related NICE technology appraisals are in development. A submission to extend the license of bendamustine to include first-line treatment of indolent NHL has already been made to the US FDA but no decision has been made as yet, and the FDA has reportedly requested further data. According to the NICE final scope documents, the evaluation of BR in MCL will consider patients who are unsuitable for stem cell transplantation, who currently receive rituximab in combination with other chemotherapy regimens (e.g. R-CHOP [most frequently used], R-FC and R-CVP). The evaluation of BR in indolent NHL will consider patients with advanced disease who require therapy, and will include similar standard comparators (e.g. R-CHOP, R- CVP). For both indolent NHL and MCL, the main supporting data consist of the Phase III study (StiL NHL ), which compared BR to R-CHOP in the first-line treatment of advanced (stage III or IV) MCL (19%) or indolent NHL (mainly follicular [54%]). The primary endpoint was median progression-free survival (PFS) in the per protocol population, this was extended by around 38 months in the BR group (69.5 months versus 31.2 months; HR 0.58; 95% CI ; p<0.0001). Separate analyses according to histological subtype found the benefit of BR to be consistent in all apart from marginal zone lymphoma. For MCL patients, the PFS benefit was 13.3 months (35.4 months versus 22.1 months; HR 0.49; ; p=0.0044). Produced for the London New Drugs Group Contact: Nicky Pocock Medicines Information Pharmacist London & South East Medicines Information Service Guy s Hospital London SE1 9RT Tel: Fax: Produced for use within the NHS. Not to be reproduced for commercial purposes R-CHOP was associated with a higher rate of serious adverse events (29% versus 19%; NNH of 10), including grade 3/4 neutropenia (69% versus 29%; p<0.0001; NNH 2-3) and leukocytopenia (72% versus 37%; p<0.0001; NNH 2-3). R-CHOP was also associated with a higher number of infectious episodes and more frequent use of G-CSF. BR was associated with a higher rate of drug-associated skin reactions (erythema or allergic reactions). The StiL study did not include any maintenance or consolidation treatment, and it is therefore not known how BR compares to R-CHOP followed by maintenance rituximab, or if rituximab maintenance has a role after first-line BR chemotherapy. Also data on the longer- safety of bendamustine are currently limited. There are no data comparing BR to other, alternative first-line treatment options (e.g. R-CVP), which clinicians may use if they wish to withhold anthracycline treatment. The results of the BRIGHT study have been presented in conference; this study however had a primary endpoint of complete response rate and timeto-event data (evaluated as secondary endpoints) were too immature for analysis at the time.

2 Background Indolent NHL The incidence of non-hodgkin s lymphoma (NHL) in the UK is approximately 18 per 100,000 people, and 40-50% of these have indolent (low-grade) disease, usually advanced (stage III/IV) at presentation (1). Types of NHL classified as indolent include follicular lymphoma (FL), small lymphocytic lymphoma (SLL), lymphoplasmacytic lymphoma and marginal zone lymphomas (MZL). Mantle cell lymphoma (MCL) has characteristics of aggressive as well indolent lymphoma (2). Indolent B cell lymphoid malignancies are characterised by slow and continuous growth, a high initial response rate, but a relapsing and progressive disease course (2). The clinical presentation, rate of disease progression and patterns of treatment for patients with indolent NHL vary widely. Active surveillance ( watchful waiting ) may be an appropriate treatment option for many, with appropriate interventions when symptoms develop. There may be multiple episodes of remission and relapse, and the nature of the disease can change at relapse, sometimes transforming to a more aggressive type (3). The most commonly used first-line treatment for symptomatic, advanced indolent NHL is rituximab plus combination chemotherapy, for example R- CVP (cyclophosphamide, vincristine, prednisolone and rituximab) or R-CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone and rituximab). Chlorambucil ± rituximab may be given to people who are unsuitable for these regimens (3). R-CHOP is the most widely used of these regimens (4). Mantle cell lymphoma MCL is a rare type of B-cell NHL that has a moderately aggressive course and is rarely curable with currently available standard treatment. The registered annual incidence of NHL in England and Wales is around 10,400, with MCL accounting for around 5 to 8% (around 670 new diagnoses per year, or 1.2 per 100,000). It usually occurs in older adults (the median age of presentation is 60 years) and has a male predominance (5). There is no current gold standard treatment for advanced-stage MCL, due to a lack of definitive data to guide treatment decisions (it is relatively uncommon and has often been included with other types of NHL in clinical trials). In the UK, patients unsuitable for autologous peripheral blood stem cell transplantation (ASCT) are most commonly treated first-line with R-CHOP or R-FC (cyclophosphamide in combination with rituximab) (final scope). Although MCL usually responds well to initial chemotherapy (response rates of 50-70% with many regimens), durations of response are short and overall survival is poor (median of 3 years) (5, 6). Licence status Bendamustine (Levact ) is currently licensed in the UK for use as monotherapy in the treatment of patients with indolent NHL who have progressed during or within 6 months following treatment with rituximab or a rituximab containing regimen. It is not licensed for use in combination with rituximab or in the first-line setting for indolent NHL, and is not licensed for the treatment of MCL (7). An application to extend the licence of bendamustine to include its use in combination with rituximab for the first-line treatment of indolent NHL and MCL has been submitted to the European Medicines Agency and a decision is expected towards the end of 2013 (1, 8). An application was filed in the US in December 2011 for use of bendamustine, in combination with rituximab, as a first-line therapy for indolent B-cell NHL. According to the New Drugs Online database, the FDA requested further data in October 2012 (no details of the data requested are given) (1). Rituximab (MabThera ) is licensed in the UK for the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy. The SPC discusses the results of three randomised trials using rituximab in combination with chemotherapy CVP, CHOP, MCP (melphalan, chlorambucil, and prednisone) and CHVP (cyclophosphamide, doxorubicin, etoposide, and prednisone)/ interferon-α (9). It is not licensed for use in the treatment of MCL or other indolent lymphomas. NICE guidance NICE is undertaking two separate technology appraisals on: 1. Bendamustine in combination with rituximab for the first-line treatment of advanced indolent non-hodgkin's lymphoma (expected in October 2013). This will look at its use in patients with previously untreated advanced, indolent NHL that requires therapy, with standard comparators including R- CVP, R-CHOP, and chlorambucil plus rituximab in those unsuitable for the former two regimens (10). 2. Bendamustine in combination with rituximab for the first-line treatment of mantle cell lymphoma (expected date of issue TBC). This will look at its use in patients who are unsuitable for stem cell transplantation, with standard comparators including R-CHOP, R-FC (plus R-CVP and chlorambucil plus rituximab in those unsuitable for the former two regimens) (11). Both are at an early stage of development and no draft recommendations are currently available.

3 Epidemiology Indolent NHL The incidence of NHL in the UK is approximately 18 per 100,000 people. If it is assumed that 45% have indolent disease, 85%* of these have stage III or IV disease, 94%* are eligible for chemotherapy, and 90% are considered suitable for bendamustine, then the population eligible for first-line treatment with BR can be estimated as around 6 per 100,000. [*These data were obtained from the costing statement from the NICE guidance on Rituximab for the for the first-line maintenance treatment of stage III- IV follicular non-hodgkin s lymphoma (TA 243) (12)]. MCL The incidence of MCL in the UK is approximately 1.2 per 100,000 people. If it is assumed that 85% have advanced disease, 90% are unsuitable for ASCT and 90% of these are considered suitable for bendamustine then the population eligible for firstline treatment with BR can be estimated as around 0.8 per 100,000. Published data StiL NHL This multicentre Phase III non-inferiority study compared bendamustine in combination with rituximab (BR) to R-CHOP in the first-line treatment of adults with advanced (stage III or IV) MCL (19%) or indolent NHL, the latter including follicular (54%), lymphoplasmacytic (Waldenstrom s macroglobulinaemia) (8%), small lymphocytic (4%), and marginal zone lymphoma (13%) (4). Participants were randomised to open-label treatment with BR (rituximab 375mg/m 2 on day 1 plus bendamustine 90mg/m 2 on days 1+2 every 4 weeks; n=274) or R-CHOP (rituximab 375mg/m 2 on day 1 plus cyclophosphamide 750mg/m 2, doxorubicin 50mg/m 2 and vincristine 1.4mg/m 2 on day 1 and prednisone 100mg daily for 5 days; n=275), for up to six cycles. No maintenance or consolidation treatment was administered. The primary endpoint was progression-free survival (PFS), and the aim was to demonstrate non-inferiority of BR to R-CHOP (the non-inferiority margin was set at 10%). A total of 549 patients were randomised to treatment and 514 were available for analysis (per protocol: 261 in the BR group and 253 in the R-CHOP group). The median age of the group was 64 years (range 34-83) and the majority had stage IV (77%) or III (19%) disease. A median of six cycles of treatment per patient was administered in both treatment arms, and full doses of treatment were given in 95.9% of BR cycles and 88.8% of R-CHOP cycles. The main results reported were as follows: At a median follow-up of 45 months, median PFS was 69.5 months (IQR 26.1-not yet reached) for BR versus 31.2 months ( ) for CHOP-R (HR 0.58; 95% CI ; p<0.0001). When separate analyses were conducted for histological subtypes, a significant benefit for BR in terms of PFS was shown for all except marginal zone lymphoma, with no significant treatment-bysubgroup interaction. For MCL, PFS was 35.4 months (IQR ) in BR and 22.1 months ( ) for R-CHOP (HR 0.49; ; p=0.0044) Overall response rates (ORR) did not differ between groups (93% with BR and 91% with R- CHOP), however more complete responses were seen in the BR group (40% versus 30%, respectively (p=0.021). The BR group also had a longer time to next antilymphoma treatment (not reached versus 42.3 months, respectively; HR 0.52; 95% CI ; p<0.0001). No difference in OS was seen (43 deaths in the B-R arm and 45 in the CHOP-R arm) but followup was limited, and the median OS had not been reached in either group. R-CHOP was more frequently associated with serious adverse events (29% versus 19% in the BR group), with a higher incidence of grade 3/4 neutropenia (69% versus 29%; p<0.0001) and leukocytopenia (72% versus 37%; p<0.0001). In addition it was associated with a higher overall rate of infectious episodes (any grade; 50% versus 37%; p=0.0025) and sepsis (3% versus <1%, respectively; p=0.019). One patient in the BR group and five in the R-CHOP group died from sepsis. G-CSF was more often used in CHOP-R treated pts (20% versus 4% of all cycles; p<0.0001). The BR regimen was associated with a lower rate of alopecia (0% versus 100%), stomatitis (6% versus 19%) and parasthesia (7% versus 29%), but a higher rate of drug-associated skin reactions (erythema [16% versus 9%] or allergic reactions [15% versus 6%]) than R-CHOP. Although R-CHOP is the most widely used chemotherapy regimen for the first-line treatment of indolent NHL and MCL, some clinicians may prefer to withhold the anthracycline, both to improve tolerability and to hold for use in the future event of histological transformation. There have been no randomised studies comparing BR to alternative treatments (e.g. R-CVP) in this setting. The StiL study did not include any maintenance or consolidation treatment, and it is therefore not known how BR compares to R-CHOP followed by maintenance rituximab, or if rituximab maintenance has a role after first-line BR chemotherapy (13).

4 Although bendamustine is well tolerated in the short term, its long-term toxicity profile may not yet be appreciated, particularly for the risk of myelodysplasia and leukaemia. There are scarce data on the effects of bendamustine on stem cell viability and collection for future ASCT, and whether its use affects response rates to subsequent treatments at relapse (13). BRIGHT study This Phase III study compared BR to standard treatment regimens (R-CHOP or R-CVP) in the first-line treatment for indolent NHL or MCL. The results of the study have not been fully published and these data have been taken from a conference abstract (presented at ASH in 2012) (14). A total of 477 participants were randomised to receive either BR (regimen as per StiL study) or R- CHOP/R-CVP (the choice of standard regimen was determined by the investigator prior to randomisation). The primary objective was to demonstrate non-inferiority of BR to standard treatment in terms of CR rate, with a non-inferiority margin (ratio) of Tumour response was determined by a blinded independent review committee (IRC). A total of 436 randomised patients received treatment and 419 were evaluable for efficacy (BR n=213; R-CHOP/R-CVP n=206 [R-CHOP 97; R- CVP n=109]). The median age of the groups was 59 years, 64% had an ECOG performance status of 0, 62% had Ann Arbor stage IV disease, and 83% had indolent NHL. Most patients completed six cycles of treatment (92% for BR and 91% for R-CHOP/R- CVP), with high relative dose intensity (>96%).The main results reported in the abstract are as follows: Among randomised patients, the rate of CR was 31% with BR and 23% with standard treatment (HR 1.34; ; p= for noninferiority). Results were similar in the evaluable population (31% versus 25%; HR 1.25; 95% CI ; p= for non-inferiority). Among randomised patients, the CR rate for those with indolent NHL was 27% for BR and 23% for standard treatment (HR 1.16; 95% CI ; p=0.1289). For those with MCL it was 51% and 24%, respectively (HR 1.95; 95% CI ; p= for superiority) For randomised patients, the ORR was 94% for BR and 84% for R-CHOP/R-CVP. Time-to-event data are immature and will be analysed at a later date. The most common adverse events for BR and R- CHOP/R-CVP, respectively, were nausea (139 vs. 102 patients), fatigue (113 vs. 107), neutropenia (76 vs. 85), constipation (65 vs. 90), and alopecia (8 vs. 74). Laboratory grade 3/4 haematological toxicities for BR and R-CHOP/R-CVP included lymphopenia (137 vs. 64), neutropenia (98 vs. 151), leukopenia (84 vs. 116), thrombocytopenia (16 vs. 15), and anaemia (6 vs. 9), respectively. The most frequent investigator-reported non-haematological grade 3/4 adverse events for BR and R-CHOP/R-CVP were infusion-related reactions (13 vs. 8 patients). G-CSF was administered at the discretion of the investigator (per ASCO recommendations) to 29% of the BR group and 43% of the R-CHOP/R-CVP group. Fatal adverse events occurred in six patients receiving BR patients (pneumonia, respiratory failure, and sepsis; acute respiratory failure; cardiac arrest; pneumonia; chronic obstructive pulmonary disease; lung cancer) and in one patient who received R-CHOP/R-CVP (sepsis). Cost Bendamustine is available in 25mg and 100mg vials at a cost of and , respectively (excluding VAT) (15). The total cost of bendamustine given at a dose of 90mg/m 2 on days 1 and 2 for six cycles (assuming an average BSA of 1.8m 2 ) can be calculated as follows: 162mg x 2 = 324mg per course 324mg = 3x100mg vials plus 1x25mg vial = 1,076 (inc. VAT) per cycle Total for six courses = 6,460 The dose of rituximab used in the BR regimen is the same as that employed in the current standard regimens (e.g. R-CHOP, R-CVP). The cost implications of treating eligible patients first-line with BR instead of these current standard regimens will therefore be based on the additional cost of bendamustine when compared with CHOP and CVP. The costing statement for TA243 (Rituximab for the first-line treatment of stage III IV follicular lymphoma) states that the CHOP component costs 229 per cycle (12), which would work out as a total cost of 1650 (inc. VAT) for six cycles. Therefore the use of BR instead of R-CHOP would be associated with additional costs of around 4,810 per patient treated. The total estimated population that could be eligible for BR in the first-line treatment of indolent NHL or MCL can be estimated at around 6.8 per 100,000 (see epidemiology section). Based on the above calculations, the additional costs associated with use of this instead of R-CHOP would be approximately 32,700 per 100,000 population. Service implications The use of BR instead of R-CHOP would be associated with increased service delivery costs [based upon the DH Chemotherapy Regimens List ].

5 Summary of Costings Drug Indication Incidence (number of patients per 100,000 eligible for this treatment) Average duration of treatment (taken from trial data) Cost per month/ cycle Cost per 100,000 population per month/ cycle Cost per 100,000 for average treatment duration Bendamustine plus rituximab First-line treatment of MCL and indolent NHL 6.8 Six cycles * 800 * 5,440 * 32,640 *costs presented are the additional costs, using R-CHOP as the standard comparator (i.e. the difference between bendamustine and CHOP, as the same rituximab dose is used in both regimens) Details of search strategy: EMBASE: exp BENDAMUSTINE/ AND exp RITUXIMAB/ AND exp *NONHODGKIN LYMPHOMA/ [Limit to: Human and English Language] MEDLINE: bendamustine.af AND rituximab.af and exp *LYMPHOMA, NON-HODGKIN [Limit to: English Language and Humans]

6 References 1. New Drugs Online database; accessed via 2. Vidal L et al (2012) Bendamustine for patients with indolent B cell lymphoid malignancies including chronic lymphocytic leukaemia. Cochrane Database of Systematic Reviews 2012, Issue 9 doi/ / cd pub2/ abstract 3. Lymphoma (non Hodgkin's) - bendamustine (with rituximab): appendix B - final scope Scope/pdf/English 4. Rummel MJ et al (2013) Bendamustine plus rituximab versus CHOP plus rituximab as first-line treatment for patients with indolent and mantle-cell lymphomas: an open-label, multicentre, randomised, phase 3 noninferiority trial. The Lancet; published early online 20 th February Lymphoma (mantle cell) - bendamustine (1st line, with rituximab): final scope action=download&o= McKay P et al (2012) Guidelines for the investigation and management of mantle cell lymphoma. British Journal of Haematology doi: /bjh mcl_guideline.pdf 7. Bendamustine (Levact ) SPC (last revised 3/8/10) 8. Personal communication with Napp Pharmaceuticals Ltd medical information (8/4/2013) 9. Rituximab (Mabthera ) SPC (last revised 25/5/12) 10. NICE technology appraisal in development (ID434): Bendamustine in combination with rituximab for the first-line treatment of advanced indolent non-hodgkin's lymphoma 11. NICE technology appraisal in development (ID609): Bendamustine in combination with rituximab for the first-line treatment of mantle cell lymphoma index.jsp?action=byid&o= Rituximab for the first-line treatment of stage III IV follicular lymphoma (review of NICE technology appraisal guidance 110) costing statement nicemedia/live/13650/57920/57920.pdf 13. Jacobson CA, Freedman AS (2013) Firstline treatment of indolent lymphoma: axing CHOP? The Lancet; published early online 20 th February Flinn IW et al (2012) An open-label, randomized study of bendamustine and rituximab (BR) compared with rituximab, cyclophosphamide, vincristine, and prednisone (R- CVP) or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R- CHOP) in first-line treatment of patients with advanced indolent non-hodgkin's lymphoma (NHL) or mantle cell lymphoma (MCL): The bright study. Blood; 120(21); abstract 902 content/abstract/120/21/902? maxtoshow=&hits=10&resultformat=&fulltext =bright&searchid=1&firstindex=0&volum e=120&issue=21&resourcetype=hwcit 15. British National Formulary edition 64 (September 2012) Please direct any comments to Nicola Pocock, London & South East Medicines Information Service, Guy s Hospital, Great Maze Pond, London SE1 9RT Tel: , Fax: The document reflects the views of LCNDG and may not reflect those of the reviewers

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