1 st Appraisal Committee meeting Background & Clinical Effectiveness Gillian Ells & Malcolm Oswald 24/11/2016

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1 Lead team presentation Nivolumab for treating recurrent or metastatic squamous-cell carcinoma of the head and neck after platinum-based chemotherapy [ID971] 1 st Appraisal Committee meeting Background & Clinical Effectiveness Gillian Ells & Malcolm Oswald 24/11/2016 1

2 Key Issues for consideration Does the trial population in CheckMate 141 accurately reflect the anticipated marketing authorisation population? Relevance of CheckMate 141 to UK clinical practice Validity of comparison of nivolumab with investigator choice (IC) which includes cetuximab and excludes paclitaxel Male to female ratio in the trial Differences in OS HR s between participants from North America and the European Union What conclusions can be made about the trial results given these limitations? Assumption of equivalence between the 3 comparators specified in NICE scope Docetaxel equivalent to paclitaxel Docetaxel equivalent to methotrexate Effectiveness of nivolumab given the differences in survival benefits within subgroup based on: PD-L1 expression HPV status 2

3 Disease background & management Head and neck cancers include tumours arising mainly in the oral cavity, pharynx and larynx Excludes tumours of the brain and related tissues In ,899 patients newly diagnosed in England & Wales >90% of malignant tumours in the head and neck are squamous cell carcinomas Risk Factors Gender Age Tobacco and alcohol use HPV status 3

4 Disease background & management 2 Squamous cell carcinoma of the head and neck (SCCHN) affects more males than females (approx. 2.4:1) Approximately 60% of patients with SCCHN present with advanced stage disease 20 30% of them go on to develop recurrent or metastatic (R/M) disease 4% of patients in the UK will present with metastatic disease Highly detrimental impact on HRQoL Functional: pain, problems eating and swallowing, dry mouth and speech difficulties Affects social and psychological wellbeing Platinum-based therapies predominantly used for SCCHN Variation in clinical practice after platinum therapy, but may include docetaxel, paclitaxel, methotrexate, cetuximab (not in the UK) No NICE guidance for SCCHN after platinum therapy 4

5 Company s proposed clinical care pathway for adults with R/M SCCHN after platinum-based therapy Patients who may be considered eligible for treatment with nivolumab under the anticipated indication for SCCHN are expected to have disease progression within 6 months of having platinum-based therapy, but may have received this therapy in either early or locally advanced disease setting Docetaxel is the most routinely-used agent in UK clinical practice for patients with R/M SCCHN who have progressed after platinum-based therapy 5

6 Patient and clinician perspectives Submissions by: Swallows Head & Neck Cancer Support Royal College of Physicians Professor Kevin Harrington Dr Anthony Kong Poor prognosis, better for patients with HPV+ and/or PD-L1+ expression Current regime: no gold standard but typically platinum-based chemo, Then paclitaxel or docetaxel-based chemo (20% response) Best supportive care Or increasingly, clinical trials (e.g. immunotherapy) Patients want better outcomes and experience, fewer side effects, better support after treatment Nivolumab: Currently available to melanoma & lung patients, little extra training needed Ideally given in dedicated cancer centres, with side-effect monitoring & 6-9 week scans Improves survival Reduces side-effects: suitable for patient unable/unwilling to have further chemo

7 Decision problem Final scope issued by NICE Decision problem addressed in the company submission Population Adults with R/M SCCHN who have previously received platinum-based chemotherapy Adults with R/M SCCHN who have previously received platinum-based chemotherapy Intervention Nivolumab Nivolumab Comparator(s) Docetaxel Paclitaxel Methotrexate Docetaxel Paclitaxel Methotrexate Outcomes Overall survival Progression-free survival Adverse effects of treatment Health-related quality of life Overall survival Progression-free survival Adverse effects of treatment Health-related quality of life 7

8 Details of technology Technology Anticipated Marketing authorisation Mechanism of action Administration Acquisition cost Nivolumab (Opdivo, Bristol-Myers Squibb) Nivolumab is indicated for the treatment of recurrent or metastatic squamous-cell cancer of the head and neck after platinum-based therapy in adults Acts as an immune-checkpoint inhibitor that targets the programmed death (PD-1) inhibitor by preventing inactivation of T-cells and restoring T-cell activity against tumour cells by harnessing the patient s own immune system to directly fight cancer cells Intravenous infusion, over 60-minutes 3 mg/kg every 2 weeks List price: (40 mg vial) and 1, (100 mg vial) Simple discount agreed with the Department of Health 8

9 Clinical evidence Trial name CheckMate 141 Population Adults with platinum-refractory R/M SCCHN Intervention Nivolumab group (n=240) 3 mg/kg, i.v. Q2W Comparator(s) Investigators choice (IC) group (n=121) Location Trial design Method of randomisation Eligibility criteria for participants Docetaxel (n=54, 47%) 30mg/m 2 i.v. QW Methotrexate (n=52,41%) 40mg/m 2 i.v. QW Cetuximab (n=15,12%) 400mg/m 2 i.v. once then 250mg/m 2 QW 55 international study sites across 15 countries in North America, South America, Europe and Asia. 34 UK patients randomised to study treatment at 5 study sites Multicentre, open-label, phase III randomised controlled trial Patients randomised (2:1) to receive either nivolumab or IC of therapy, with stratification by prior cetuximab treatment (yes or no) Key inclusion criteria: Males and females 18 years of age Tumour progression or recurrence within 6 months of last dose of platinum therapy in the adjuvant, primary, recurrent, or metastatic setting Outcomes Primary outcome: OS Secondary outcomes: PFS, Objective response rate (ORR) Exploratory endpoints: Duration of response (DOR), time to response (TTR), safety and patient reported outcomes (PRO s) 9

10 Equivalency in OS of comparators Data from the company submission (CS) suggests: Limited direct evidence from clinical trials that assess relative efficacy of docetaxel, methotrexate and paclitaxel versus one another or nivolumab or against best supportive care (noted in British Association of Head and Neck Oncologists 2011 guidelines) Clinical expert opinion is that the taxanes (docetaxel and paclitaxel) and methotrexate have similar efficacy in terms of OS although differences in safety profiles exist ITT results from the IC arm of CheckMate 141 are therefore considered applicable to all three comparators included in this appraisal Clinical evidence for the safety and efficacy of nivolumab versus docetaxel and methotrexate is available as part of the IC arm of CheckMate 141 Cetuximab (monotherapy) is also included in the IC arm of CheckMate 141 but not believed to be routinely used in UK clinical practice 10

11 Overall survival results CheckMate 141 met primary endpoint with nivolumab demonstrating significant improvements in OS relative to IC arm (HR 0.70 [97.73% CI, 0.51 to 0.96; p=0.0101]), = 30% reduction in the risk of death with nivolumab versus IC of therapy Abbreviations: CI: confidence intervals; HR: hazard ratio; OS: overall survival. Source: Gillison et al. (2016) 11

12 Secondary efficacy results PFS Median PFS was similar between treatment arms; however, a delayed separation of Kaplan-Meier curves in favour of nivolumab was observed (HR, 0.89; 95% CI, 0.70, 1.1; p=0.3236) Abbreviations: CI: confidence intervals; HR: hazard ratio; PFS: progression-free survival; RECIST: Response Evaluation Criteria In Solid Tumours. Source: Ferris et al. (2016)9 12

13 Outcome summary table Outcome Nivolumab (n=240) IC (n=121) Overall Survival Deaths, n (%) 133 (55.4) 85 (70.2) Median OS, months (95% CI) 7.5 (5.5, 9.1) 5.1 (4.0, 6.0) HR for death with nivolumab (97.73% CI; p-value) b 0.70 (0.51, 0.96; p=0.0101) 1-year survival rate, % (95% CI) 36.0 (28.5, 43.4) 16.6 (8.6, 26.8) Progression-free survival Events, n (%) 190 (79.2) 103 (85.1) Median PFS, months (95% CI) 2.0 (1.9, 2.1) 2.3 (1.9, 3.1) HR for progression or death with nivolumab (95% CI; p-value) 0.89 (0.70, 1.1; p=0.3236) 6-month PFS rate, % (95% CI) 19.7 (14.6, 25.4) 9.9 (5.0, 16.9) Tumour response ORR, n (%) 32 (13.3) 7 (5.8) [95% CI] [9.3, 18.3] [2.4, 11.6] Median TTR, months (range) 2.1 ( ) 2.0 ( ) Abbreviations: CI: confidence intervals; HR: hazard ratio; IVRS: interactive voice response system; ORR: objective response rate; OS: overall survival; PFS: progression-free survival; RECIST: Response Evaluation Criteria In Solid Tumours; TTR: time to response. Source: Gillison et al. (2016), Ferris et al. (2016) and CheckMate 141 CSR (7th June 2016) 13

14 Patient-reported HRQoL outcomes: CheckMate 141 Patient-reported outcomes evaluated using the EORTC QLQ-C30 and head-and-neckspecific module (QLQ-H&N35), with clinically meaningful changes defined as a change from baseline of 10 points. Health problems and perceived health status also assessed using the EQ-5D-3L EORTC QLQ-C30 & EORTC QLQ-H&N35 ************ ************ Significant differences between treatment arms observed in favour of nivolumab at both Weeks 9 and 15 compared to IC arm for some functional domains and symptoms Time to deterioration was significantly delayed for nivolumab versus IC for some functional domains and symptoms EQ-5D-3L During the first 21 weeks of follow-up, health problems were more prevalent in the IC arm relative to nivolumab, with a >10% difference in the percentage of patients reporting health problems for ******* ******* *** **** * 14

15 Sub-group analysis Exploratory pre-planned subgroup analyses conducted in CheckMate 141 included OS by treatment group and: PD-L1 expression ( 1% or <1%) HPV-p16 status (positive or negative) Selected baseline characteristics Company stated that nivolumab demonstrated reductions in the hazard rate of death versus IC, regardless of PD-L1 expression, HPV-p16 status and selected baseline characteristics, including intended therapy for the IC arm Notably, with regards to PD-L1 expression, no further benefit in OS was reported at increasing levels of PD-L1 expression ( 5% and 10%) Company also stated that results demonstrate that the improved efficacy of nivolumab versus IC of therapy is generalisable across all relevant subgroups of patients included in the CheckMate 141 trial 15

16 OS results by PD-L1 expression Company s submission figure 15, page 70 16

17 OS results by HPV-p16 status Company s submission figure 16, page 71 17

18 OS results for selected baseline characteristics Company s submission figure 17, page 71 18

19 Adverse events Adverse event, n (%) Nivolumab (n=236) IC (n=111) Deaths 132 (55.9) 78 (70.3) Deaths due to study drug toxicity 2 (0.8) 0 Any grade Grade 3-4 Any grade Grade 3-4 All causality AEs 229 (97.0) 97 (41.1) 109 (98.2) 58 (52.3) Drug-related AEs 139 (58.9) 31 (13.1) 86 (77.5) 39 (35.1) All-causality SAEs 127 (53.8) 66 (28.0) 66 (59.5) 36 (32.4) Drug-related SAEs 16 (6.8) 11 (4.7) 17 (15.3) 12 (10.8) All-causality AEs leading to treatment discontinuation 51 (21.6) 27 (11.4) 27 (24.3) 12 (10.8) Drug-related AEs leading to treatment discontinuation 9 (3.8) 6 (2.5) 11 (9.9) 7 (6.3) Treatment discontinuations due to any grade AE (all causality) were similar between groups (21.6% nivolumab versus 24.3% IC) No new safety concerns with nivolumab were identified in CheckMate

20 Summary of ERG critique(1) Mismatch between the population referenced in the anticipated marketing authorisation for nivolumab and the trial population of CheckMate 141 MA: R/M SCCHN after platinum-based chemotherapy Trial: R/M SCCHN which has progressed within 6 months of treatment with platinumbased chemotherapy Results from CheckMate 141 have limitations relating to applicability to clinical practice in England and Wales: Lacks comparison with one of the comparators in the NICE scope, paclitaxel No direct comparison with comparators specified in NICE scope, but with IC, which permits clinician choice of treatment IC arm includes a treatment not specified in the NICE scope, cetuximab Variation by individual therapy observed with nivolumab performing particularly well versus cetuximab (HR=0.54) as opposed to versus docetaxel (HR=0.84). Further analyses demonstrated little effect of removing cetuximab patients and a *** in the advantage of nivolumab versus IC from a HR (97.73% CI) of 0.70 (0.51, 0.96; p=0.0101) to * ** Limited evidence supported by clinical opinion suggests paclitaxel is likely to be more effective than docetaxel and therefore possibly more effective than nivolumab 20

21 Summary of ERG critique(2) Company submission shows that the prevalence of males in UK population is approximately 70% vs. 83.1% in the trial population. Given that discrepant results are reported for OS - HR 0.65 (0.48 to 0.88) and 0.93 (0.47 to 1.85) for males and females respectively, this issue might influence the applicability of study results to the overall UK population ERG noticed differences in the OS HRs between participants from North America and the European Union (EU), i.e (95% CI 0.36 to 0.85) and 0.91 (95% CI 0.62 to 1.33), respectively Company s response: lower proportion of human papillomavirus (HPV)-positive and never smoker patients in Europe, an imbalance of HPV status across treatment arms within the European subgroup and differences in choice of IC of therapy Differences in the recorded baseline characteristics between the EU and North America as well as in the treatments chosen highlights the potential for lack of applicability to the UK Concerns regarding use of subsequent therapies and imbalances between nivolumab and IC arms of CheckMate 141. Further analyses suggested treatment effect of nivolumab versus IC is not affected by the type or timing of subsequent systemic therapy received in each treatment arm 21

22 Equality Issues No issues identified during scoping and in the consultee submissions 22

23 Key Issues for consideration Does the trial population in CheckMate 141 accurately reflect the anticipated marketing authorisation population? Relevance of CheckMate 141 to UK clinical practice Validity of comparison of nivolumab with investigator choice (IC) which includes cetuximab and excludes paclitaxel Male to female ratio in the trial Differences in OS HR s between participants from North America and the European Union What conclusions can be made about the trial results given these limitations? Assumption of equivalence between the 3 comparators specified in NICE scope Docetaxel equivalent to paclitaxel Docetaxel equivalent to methotrexate Effectiveness of nivolumab given the differences in survival benefits within subgroup based on: PD-L1 expression HPV status 23

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