PD-(L)1 checkpoint inhibitors to reach $58 Billion by 2025
PD-1/PD-L1 checkpoint inhibitors significantly outperformed the global oncology market, growing at 5-year CAGR of 45%, or three times the rate of oncology overall, and are expected to reach $58 billion globally by 2025
Author - MARKUS GORES, Vice President, European Thought Leadership, IQVIA Research
BIOMARKERS: AT THE CENTRE OF SUCCESS
From the very beginning, biomarkers have been an integral part of the story of the PD-1/PD-L1 checkpoint inhibitors.
Undoubtedly, Keytruda was in the right place, at the right time, for their patient selection based high PD-L1 expression strategy to be so successful. However, the importance of biomarkers for the success of PD-1/PD-L1 inhibitors cannot be overstated, and it is only growing.
In an increasingly crowded marketplace, competitors need to demonstrate differentiated value, e.g. by targeting sub-populations with high unmet need and by ‘guaranteeing’ positive patient outcomes, for which diagnostic and predictive biomarkers are essential.
The high noise level generated by the two leading PD-1/ PD-L1 incumbents, Keystruda and Opdivo, further raises entry barriers to the market and it demands commercial precision from later entrants with smaller checkpoint inhibitor franchises to be able to compete successfully.
THE RISE OF COMBINATIONS
The vast majority, 83%, of current clinical trials test combinations of PD-1/PD-L1 inhibitors with a broad range of modalities, spanning other immunotherapies, targeted therapies, chemotherapies and radiotherapies.
There is a plausible rationale for exploring combinations to overcome resistance and achieve a deep and durable response, including stimulating a stronger T-cell response, e.g. by blocking other inhibitory checkpoints; the direct modification of tumour immunogenicity, e.g. via chemotherapy, radiotherapy or oncolytic viruses; or a multi-pathway attack using other targeted therapies, e.g. VEGF or PARP inhibitors.
For all the uncertainty surrounding individual innovation efforts, collectively, the ongoing frantic development activity will lead to overwhelming complexity of the future PD-1/PD-L1 treatment landscape. This goes beyond the sheer number of available therapies and raises many practical questions for oncologists and payers alike, for example: How and when to combine different agents? How many agents to combine, e.g. double or triple stacked treatments? How to sequence such combinations? How to assess the differential value of different combinations against which standard of care, and against each other?
The challenges caused by such overwhelming complexity drive an even greater need for diagnostic and predictive biomarkers to diagnose and treat patients with ever greater precision, e.g. accurately identifying high responders for a given treatment regimen and predicting the occurrence of adverse events, to enable the optimal use of the emerging, vast armamentarium of future PD-1/PD-L1 therapies - which ONCY is addressing with pelareoep in combination with multiple PD-1/PD-L1 therapies in its objective to increase the current 10-20 % effectiveness of PD-1/PD-L1 therapies by a factor of 1 or 2 times higher.