Report Library
All ReportsThe Emergence of PD-1 Immunotherapies: An Analysis Between Keytruda and Opdivo in NSCLC
*Included free with BioMedTracker Subscription - click here to log inJanuary 05, 2017
Over the past several decades, scientists have been working on developing therapies that harness the power
of the immune system to fight cancer. Different immunotherapeutic approaches have been appraised to treat
different types of cancer and all had very limited success. However, this changed when the checkpoint signaling
pathway involving both the programmed death 1 (PD-1) receptor and its ligands, PD-L1/2 were discovered.
In September 2014, Merck’s Keytruda (pembrolizumab) became the first of the PD-1 immunotherapy family to gain approval in the US for the treatment of patients with advanced or unresectable melanoma. Later in December 2014, Opdivo (nivolumab) became the second anti-PD-1 inhibitor to be approved in the US for the same indication. The development of these inhibitors marks the beginning of PD-1/L1 immunotherapy development across a wide range of cancers. However, by examining the drugs’ history and comparing their sales, it is evident that both competitors are very different. Previously, both Keytruda and Opdivo were considered by doctors as practically the same, in terms of efficacy and safety in second-line non-small cell lung cancer (NSCLC). But mid-way through 2015, Opdivo’s sales began to outpace Keytruda’s and since then have over tripled Keytruda’s sales.
The key to Opdivo’s success can be partially attributed to the company’s first to market approval in squamous NSCLC, which makes up between 20% to 30% of total NSCLC patients. Keytruda was first to market in both melanoma and non-squamous NSCLC, but Bristol-Myers Squibb’s (BMS) early approval in squamous NSCLC and updated National Comprehensive Cancer Network (NCCN) guidelines early in 2015 allowed BMS to position the drug in both disease subtypes far before it received FDA approval in non-squamous NSCLC. Following approval in non-squamous NSCLC, Opdivo took control of the PD-1 market because of its FDA approval with no biomarker test requirement and Merck’s Keytruda struggled due to its approval which required a biomarker test and was limited for patients whose tumors expressed PD-L1 in 50% or more tumor cells.
PD-1 and PD-L1 inhibitors are projected to experience considerable growth as they have proven to be more successful in shrinking tumors in various types of cancers, as compared to other immunotherapies. This report analyzes the developmental similarities and differences between Keytruda and Opdivo, for both second-line and the recent news of first-line approval in NSCLC – focusing primarily on each company’s market strategy in the US. Additionally, this report examines the concerns of biomarker test reliability, the difference in academic institution vs. community treatment settings for NSCLC, and provides an outlook for the future of all approved and late-stage PD-1/L1 therapies in NSCLC.
Note: This report was published under the Informa report store in December 2016.
In September 2014, Merck’s Keytruda (pembrolizumab) became the first of the PD-1 immunotherapy family to gain approval in the US for the treatment of patients with advanced or unresectable melanoma. Later in December 2014, Opdivo (nivolumab) became the second anti-PD-1 inhibitor to be approved in the US for the same indication. The development of these inhibitors marks the beginning of PD-1/L1 immunotherapy development across a wide range of cancers. However, by examining the drugs’ history and comparing their sales, it is evident that both competitors are very different. Previously, both Keytruda and Opdivo were considered by doctors as practically the same, in terms of efficacy and safety in second-line non-small cell lung cancer (NSCLC). But mid-way through 2015, Opdivo’s sales began to outpace Keytruda’s and since then have over tripled Keytruda’s sales.
The key to Opdivo’s success can be partially attributed to the company’s first to market approval in squamous NSCLC, which makes up between 20% to 30% of total NSCLC patients. Keytruda was first to market in both melanoma and non-squamous NSCLC, but Bristol-Myers Squibb’s (BMS) early approval in squamous NSCLC and updated National Comprehensive Cancer Network (NCCN) guidelines early in 2015 allowed BMS to position the drug in both disease subtypes far before it received FDA approval in non-squamous NSCLC. Following approval in non-squamous NSCLC, Opdivo took control of the PD-1 market because of its FDA approval with no biomarker test requirement and Merck’s Keytruda struggled due to its approval which required a biomarker test and was limited for patients whose tumors expressed PD-L1 in 50% or more tumor cells.
PD-1 and PD-L1 inhibitors are projected to experience considerable growth as they have proven to be more successful in shrinking tumors in various types of cancers, as compared to other immunotherapies. This report analyzes the developmental similarities and differences between Keytruda and Opdivo, for both second-line and the recent news of first-line approval in NSCLC – focusing primarily on each company’s market strategy in the US. Additionally, this report examines the concerns of biomarker test reliability, the difference in academic institution vs. community treatment settings for NSCLC, and provides an outlook for the future of all approved and late-stage PD-1/L1 therapies in NSCLC.
Note: This report was published under the Informa report store in December 2016.
Indications Covered: | Non-Small Cell Lung Cancer (NSCLC) |
Additional Resources: