Novel Cancer Immunotherapy Clinical Trials Emerging Trends

Novel Immunotherapies To Redefine The Cancer Therapy Market Landscape Says Kuick Research


Targeted therapies such as immunotherapy harness the potential of immune system to selectively target the cancer cells. Till date, wide range of immunotherapeutic approaches including therapeutic antibodies, immune checkpoint inhibitors, vaccines, interferon, and others have entered the global market which has demonstrated huge clinical success. However, drug resistance is one of the major limitations which restrain its growth in the global market. While large number of immunotherapeutic approaches has shown success as monotherapy, research studies are now focused on evaluating their potential in combination therapy to maximize its therapeutic potential. Each immunotherapeutic combination may have a unique mechanistic synergism, which offers a complicated yet potentially rewarding feat in the field of immuno oncology.


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The progress in the field of bioinformatics has led to identification of several next generation immune checkpoint targets, like lymphocyte activation gene-3 (LAG-3), T cell immunoglobulin and mucin-domain containing-3 (TIM-3), T cell immunoglobulin and ITIM domain (TIGIT), V-domain Ig suppressor of T cell activation (VISTA), and so on.  All these next generation immune checkpoint inhibitors have shown encouraging response in combination with PD-1/PD-L1 or CTLA-4 inhibitors, which will also have a positive impact on the growth of market.


In March 2022, US FDA has granted approval to relatlimab, a novel LAG-3 inhibitor in combination with nivolumab. The drug is sold under the brand name Opdualag and is marketed by Bristol Myers Squibb.  Recently in July 2022, Bristol Myers Squibb nnounced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of the fixed-dose combination of nivolumab and relatlimab for the first-line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents. The drug is also expected to gain approval in other regions during the forecast period which will boosts its growth in the overall market.


Apart from this, the pipeline of LAG-3 inhibitor is highly crowded with more than 50 ongoing clinical trials. The major drugs in clinical development include IMP701, FS118, TSR-033, Eftilagimod Alpha, Tebotelimab, ABL501, and several others which are rapidly demonstrating positive response in clinical trials. For instance, a data from phase-II trial showed that LAG-3 inhibitor eftilagimod alpha in combination with pembrolizumab (Keytruda) is safe and has antitumor activity as first-line therapy for metastatic non-small cell lung cancer, regardless of PD-L1 status. Thus, this suggests encouraging response of LAG-3 inhibitor combination immunotherapy during the forthcoming years.      


Several pharmaceutical companies have also developed a robust pipeline of TIGIT inhibitors in their pipeline indicated for the management of several cancers. Current clinical trials are mainly evaluating the role of TIGIT inhibitors in combination with PD-1/PD-L1 inhibitor or CTLA-4 inhibitors. The extensive research activities have led to development of robust clinical pipeline of TIGIT inhibitor drugs including Tiragolumab, Ociperlimab, Vibostolimab, ASP-8374, and COM902.


TIM3 is another immune checkpoint inhibitor which has also gained interest from pharmaceutical companies. In comparsion to LAG-3 and TIGIT, the pipeline is small. However, it is believed that with the rising interest from government and investments from pharmaceutical companies will boosts the number of clinical pipeline products during the forecast period.  Cobolimab developed by Tesaro Therapeutics is one of the advanced stage TIM-3 inhibitors which are currently being evaluated in phase-II clinical trial. Recent data has shown that anti–TIM-3 antibody cobolimab is well-tolerated as monotherapy and in combination with the PD-1 inhibitor dostarlimab.


The promising response of combination cancer immunotherapy in clinical studies as well as in market has surged the pharmaceutical investments in this domain. Several key players in the market have also adopted strategic alliances such as collaboration, partnerships, or joint ventures to drive the growth of market. For instance, in December 2021, Novartis has signed an option, collaboration and license agreement with BeiGene for ociperlimab (BGB-A1217), expanding the company’s research and development activities in immuno-oncology.


Apart from immune checkpoint inhibitors, research studies are also evaluating vaccines in combination therapy. Recently in 2022, Elicio Therapeutics has entered into a clinical supply agreement with Regeneron to evaluate the safety and efficacy of Elicio’s lead asset, ELI-002, an investigational KRAS-targeted cancer vaccine, in combination with Regeneron’s Libtayo (cemiplimab) in patients with KRAS mutated cancers. The trial is expected to begin in 2023. All these factors suggest promising future of combination immunotherapy.


As per our report findings, the global combination cancer immunotherapy will grow with high CAGR rates which are mainly attributed to its encouraging response and superior efficacy in comparison to monotherapy. Apart from this, the novel approach also aids in targeting the multifactorial nature of cancer. Till date, more than 10,000 clinical trials are ongoing in global combination cancer immunotherapy market which also suggests their promising growth during the forecast period.




Neeraj Chawla

Research Head

Kuick Research





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