PD-1/L1 Immunotherapies: Historical Sales and Market Trend Analysis Report
PD-1/L1 Immunotherapies: Historical Sales and Market Trend Analysis Report
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Bristol-Myers Squibb’s (BMS) Opdivo (nivolumab) has outpaced Merck’s Keytruda (pembrolizumab) primarily
in non-small cell lung cancer (NSCLC) because of its early approval in squamous NSCLC, updated National
Comprehensive Cancer Network (NCCN) guidelines in 2015,
- Description
- Contents
Opdivo’s approval in squamous NSCLC proves pivotal in laying the foundation for the drug in the biggest
available market
Approval in non-squamous NSCLC for both Keytruda and Opdivo was not received until the fourth quarter of
2015, however, the decision that BMS made in their FDA filing for squamous NSCLC first triggered a turning
point for the drug, propelling it to almost double Keytruda sales in 2015. In March 2015, Opdivo received
approval by the FDA for the treatment of patients with metastatic squamous NSCLC with progression on or
after platinum-based chemotherapy4. At the time, the approval of Opdivo in squamous NSCLC was recognized
as modest because patients with that type of lung cancer only comprise about 29% of the US NSCLC market5.
In hindsight, the approval of Opdivo in squamous lung cancer was pivotal in helping it reach much higher sales
than Keytruda in 2015. The approval’s significance was demonstrated by the fact that patients were being
treated with Opdivo within 48 hours of its approval and there was virtually 100% access with no barriers within
approved indications by any payers6.
Prior to their approvals in non-squamous NSCLC, Opdivo and Keytruda followed two distinct paths in terms
of sales focus. Merck reported during its second quarter earnings call in 2015 that 85% of Keytruda use was
in melanoma, of which about 70% were on-label7. Conversely, BMS reported that Opdivo was at parity with
Keytruda in second line melanoma in the community setting and noted during the call that the company
was experiencing rapid penetration in second line NSCLC (for more information on academic institutional vs
community setting, please see section ‘Concerns of biomarker test reliability and higher reported use of Opdivo
in the community setting affect Keytruda’s sales’). Specifically, two-thirds of new patients with squamous
NSCLC were being prescribed Opdivo and the company also reported some off-label use in front line melanoma
and second line non-squamous NSCLC8.
Contents
Historical Sales and Market Trend Analysis 5
A look into how Bristol-Myers’ Opdivo took control of the PD-1 immunotherapy market 5
Opdivo’s approval in squamous NSCLC proves pivotal in laying the foundation for the drug
in the biggest available market 6
Merck’s limitation to PD-L1 positive patients constrains its sales 8
Concerns of biomarker test reliability and higher reported use of Opdivo in the community
setting affected Keytruda’s sales 9
Merck and Bristol-Myers shift towards a focus in first-line NSCLC 12
Reported increase in testing rates as both companies focus on becoming the standard of care
in first-line lung cancer 12
Opdivo fails as a first-line monotherapy for NSCLC 14
Bristol-Myers now focused on combination studies for Opdivo 15
The challenge for other PD-1/L1 immunotherapies recently approved and in late stage development 17
Future outlook of approved and late-stage PD-1/L1 therapies in Non-Small Cell Lung cancer 22
Keytruda sales growth from first-line NSCLC approval will be slow 22
Table of Figures
Figure 1. Sales Comparison for Opdivo and Keytruda 5
Figure 2. Non-Small Cell Lung Cancer Prevalence Breakdown 7
Figure 3. 2014-2015 Approvals of Opdivo and Keytruda in Melanoma and Non-Small Cell Lung Cancer 9
Figure 4. Treatment in Academic Institutions vs. Community Settings 11
Figure 5. Percentage Breakdown of Sales for Opdivo and Keytruda by Cancer Type 12
Figure 6. US Incidence Numbers for Indications Where Opdivo and Keytruda are Approved 14
Figure 7. First-Line NSCLC Monotherapy Study Results Comparison Between Opdivo and Keytruda 13
Figure 8. Significant CheckMate 227 Study Amendments 16
Figure 9. PD-1/L1 Inhibitor Pipeline Development Snapshot 19
Figure 10. Number of Ongoing Phase I-III Industry PD-1/L1 Inhibitor Trials 21
Figure 11. Breakdown of Patients Eligible to Receive Keytruda in First-Line NSCLC 23
Figure 12. Regulatory Catalysts for Opdivo, Keytruda, Tecentriq, avelumab, and durvalumab (2017-2023) 24
A large pool of second-line patients are still eligible for Opdivo 23
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