Pembrolizumab weight based dosing – A call for policy change

Patel, Amol; Akhade, Amol; Parikh, Purvish M.; Sharma, Atul; Malhotra, Hemant; Prabhash, Kumar; Babu, Govind; Noronha, Vanita; Batra, Ullas; Mehta, Prashant G.; Gupta, Vineet; Radhakrishnan, Venkatraman; Boya, Rakesh Reddy; Biswas, Bivas

doi:10.1055/s-0042-1742651

Cited by 4 publications

(3 citation statements)

References 26 publications

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“…Multiple studies have shown that optimizing dosing schedules can reduce treatment costs 10,25,30,[39][40][41]46 . Our current estimates of savings after hybrid dosing are in line with previously estimated savings of 8-13•79% for nivolumab 25,26,37 and 16-26•4% for pembrolizumab 10,25,26,37,41,46 .…”

Section: Discussionmentioning

confidence: 99%

“…14 Hence the selection of 150 mg as a triweekly fixed-dose would have seemed to be more appropriate and would match the fixed-dose approach of nivolumab, atezolizumab, durvalumab, avelumab which all have fixed-dose recommendations based on average body weights of 75-80 kg which resemble the average body weights of real-life oncology patients more closely. 9,10,14,[21][22][23][24][25][26][37][38][39][40][41] In a recent physiologically based pharmacokinetic (PBPK) modeling paper, however, it was reported that a 200 mg fixed-dose is required to ensure near-maximum target saturation in the intratumoural environment, even in extreme tumour conditions. 34,42 It might be uncertain however, whether pembrolizumab's intratumoural concentration is clinically relevant for efficacy.…”

Section: Scientific Basis For Alternative Dosing Strategiesmentioning

confidence: 99%

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Alternative dosing strategies for immune checkpoint inhibitors to improve cost-effectiveness: a special focus on nivolumab and pembrolizumab

Malmberg¹,

Zietse²,

Dumoulin³

et al. 2022

The Lancet Oncology

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Section: Discussionmentioning

confidence: 99%

Section: Scientific Basis For Alternative Dosing Strategiesmentioning

confidence: 99%

Alternative dosing strategies for immune checkpoint inhibitors to improve cost-effectiveness: a special focus on nivolumab and pembrolizumab

Malmberg¹,

Zietse²,

Dumoulin³

et al. 2022

The Lancet Oncology

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“… 4 Pembrolizumab 2 mg/kg once every 3 weeks has been recommended by Indian medical oncologists, and since the average weight of Indian patients is around 50-55 kg (lower than in western populations), this dose is approximately 50% of the fixed dose of 200 mg once every 3 weeks used in many clinical trials. 5 By adopting per-weight dosing, expenditure can be reduced to half without compromising efficacy. However, even this strategy has only a minor effect to improve access.…”

Section: Introductionmentioning

confidence: 99%

Effectiveness of Immune Checkpoint Inhibitors in Various Tumor Types Treated by Low, Per-Weight, and Conventional Doses at a Tertiary Care Center in Mumbai

Patel,

Hande,

et al. 2024

JCO Glob Oncol

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PURPOSE The cost of immune checkpoint inhibitors (ICIs) limits their accessibility to a small number of patients with cancer in low- and middle-income countries. Early-phase clinical trials have shown target inhibition and high activity at doses lower than those registered and evaluated in clinical trials. Here, we report everyday experience of using ICIs in 100 Indian patients, many of whom received lower doses of ICIs. METHODS Consecutive patients who received at least one dose of an ICI irrespective of tumor type at a tertiary care hospital in Mumbai, India, that was able to access ICIs for its patients were enrolled. The objectives were to study the doses used over a 3-year time period, and the effectiveness of therapy, assessed primarily by the overall response rate (ORR), overall survival (OS), and progression-free survival were secondary end points. RESULTS Twenty-five patients were treated with conventional doses of ICIs, 29 patients received lower doses per body weight, and 46 patients received low-dose treatment. The median number of cycles received was 5 (range, 1-28). Seventy-eight patients received ICIs in a palliative setting. The median follow-up time was 10.2, 9.8, and 3.9 months for those receiving fixed approved dosing, per body weight dosing, and low-dose treatment, respectively. There was a trend with time to prescribe lower doses. Response evaluation was available for 92 patients. Twenty-one (five-adjuvant and 16-palliative) patients received ICIs only. The ORR did not differ statistically among different dosing groups, but comparisons are confounded by inclusion of different ICIs, different tumor sites, and concurrent treatments. The median OS was 6.8 (range, 4.6-9.0) months. CONCLUSION Adoption of per-body weight and lower dosing of ICIs appears to give acceptable outcomes. Lower dosing can improve access and timely delivery of ICIs in low- and middle-income countries.

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Practical Consensus Guidelines on the Use of Cetuximab in Head and Neck Squamous Cell Carcinoma (HNSCC)

Parikh,

Biswas,

Dhamne

et al. 2024

South Asian J Cancer

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Head and neck squamous cell carcinoma (HNSCC) is the most common malignancy group in India and several other low- and middle-income countries. Currently, majority of the patients present in advanced stage where systemic therapy is standard of care. Multiple relapses are also not uncommon. Almost all HNSCC tumors have epidermal growth factor receptor (EGFR) overexpression, making an attractive target. Cetuximab is the most successful method to target EGFR in HNSCC. After decades of its use, it still is a prominent part of the current management guidelines. Since other agents have also been proven to be useful, we felt it was necessary to develop a real-world consensus guideline to help the decision-making process among the community oncologists. Our expert committee therefore put together currently available data, insights from their real-world clinical practice, and voted to arrive at a consensus. These consensus guidelines represent how cetuximab should be used today in the management of HNSCC.

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Pembrolizumab weight based dosing – A call for policy change

Cited by 4 publications

References 26 publications

Alternative dosing strategies for immune checkpoint inhibitors to improve cost-effectiveness: a special focus on nivolumab and pembrolizumab

Alternative dosing strategies for immune checkpoint inhibitors to improve cost-effectiveness: a special focus on nivolumab and pembrolizumab

Effectiveness of Immune Checkpoint Inhibitors in Various Tumor Types Treated by Low, Per-Weight, and Conventional Doses at a Tertiary Care Center in Mumbai

Practical Consensus Guidelines on the Use of Cetuximab in Head and Neck Squamous Cell Carcinoma (HNSCC)

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