Fierce Competition Amongst Checkpoint Inhibitor Developers Ahead

Over the next ten years, PD-(L)1 inhibitors will continue to dominate the checkpoint modulators market, says leading data and analytics companyGlobalData. PD-(L)1 inhibitors are now being explored for the treatment of new cancers such as pancreatic cancer, acute myeloid leukaemia and non-small cell lung cancer indications in combination trials and in adjuvant settings for melanoma and renal cell carecinoma.

Checkpoint Inhibitors, the latest strategy in cancer immunotherapy, have shown promising results in treating several oncology indications including a range of solid tumour types such as melanoma and non-small cell lung cancer.

Eva Grey,Healthcare Analyst at GlobalData, commented “To date the number of checkpoint inhibitors being trialled has grown over three-fold since the start of 2015. Whilst currently 21 targets are currently being trialed for the development of Immune Checkpoint Modulators, the majority of trials (>90%) are governed by PD-1, PD-L1 and CTLA4 targets.’’

The promising impact of PD-(L)1 and CTLA-4 checkpoint inhibitors has garnered substantial interest by pharma companies due to a faster drug approval process and exclusivities awarded. The scope of commercial success for checkpoint modulator developers is large but still in its early stages.

Grey continued, “Checkpoint therapies have been successful in attracting major pharma and biotech companies with many opportunities for exponential growth in both clinical and market success.’’

Initially the race began with the approval of Bristol-Myers Squibb’s CTLA-4 binding antibody, Yervoy in March 2011 following Merck and Co.’s Keytruda and jointly developed Opdivo by BMS and Ono Pharmaceuticals Ltd. Both Opdivo and Keytruda have led the number of approved indications for PD-(L)1 checkpoint inhibitors, with 5 and 6 approvals respectively.

In the US, Keytruda and Opdivo lead had the highest number marketed PD-(L)1 checkpoint modulator regulatory designations with 31 and 23 awarded respectively, reflecting the degree of extensive clinical development undertaken and the use of PD-(L)1 checkpoint modulators.

Companies marketing PD-(L)1 checkpoint modulator drugs are using precedent strategies similar to those used in the success of major blockbusters in the oncology area such as Herceptin and Avastin, for optional market success and extended clinical research.

These strategies include exploring the use of PD(L)1 inhibitors in combination with chemotherapy or as backbone therapies for immuno-oncology candidates. Already marketed PD-(L)1 inhibitors cover 16 cancer types and are being explored in clinical trials for the treatment of other cancer types.

Grey added, ‘‘Checkpoint therapies show a range of uses in clinical research, but there is plenty of market share available to adopt these drugs. The benefits of market access for checkpoint inhibitors are plentiful; developers have the upper-hand in an approach to markets and gaining first to market and first in class approvals.’’

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