One of the most recent proteins to catch the interest of scientists and pharmaceutical businesses is LAG3. Its role as an immunological checkpoint has made it a target for numerous medications that are being developed and tested in clinical settings with the intention of preventing it from suppressing the immune system. The most promising outcomes have been shown with monoclonal antibodies, one of several immunotherapy strategies that have been evaluated to target this newly discovered protein. As a result, numerous monoclonal antibodies against the LAG-3 have been created, and a number of them have advanced to later phases of clinical trials, including phase III. Given the strong clinical pipeline and the FDA and EMA approval of one LAG-3 inhibitor, the future of LAG-3-targeting monoclonal antibodies appears promising.
Global LAG-3 Inhibitor Market, Drug Sales, Price & Clinical Trials Insight 2028 Report highlights:
- Global LAG-3 Inhibitor Drug Market Opportunity Assessment
- Number Of LAG-3 Inhibitor Drugs In Market: 1 Drug
- Approved LAG-3 Inhibitor Drug Dosage, Patent & Pricing Insight
- Number Of LAG-3 Inhibitor Drugs In Clinical Trials: > 35 Drugs
- LAG-3 Inhibitor Drugs Clinical Trials Insight By Company, Country, Indication, & Phase
- LAG-3 Targeted Therapy Approaches
- Competitive Landscape: Company Financials & Anti LAG-3 Antibodies in Trials
One of the candidates farthest in clinical trial is Fianlimab (REGN3767). It was developed by Regeneron Pharmaceuticals and is currently in the final stages of clinical evaluation as a first-line adjuvant melanoma therapy. It is also participating in a phase III clinical trial to determine whether Fianlimab (anti-LAG-3), Cemiplimab (anti-PD-1), or both are superior to Pembrolizumab alone (anti-PD-1). In advanced melanoma, combining LAG-3 and PD-1 inhibition has showed promise, although it has proven difficult to achieve response rates above 50%. In clinical trials, the cohort with PD-1/PD-L1 experience showed an objective response rate (ORR) of 13%. Updated data for one PD-1/PD-L1-naive cohort showed an ORR of 62.5%, and an ORR of 65% was observed in a recently disclosed independent confirmatory cohort.
Opdualag, a first-in-class LAG-3 inhibitor, was commercialized after Bristol Myers Squibb became the first company to receive approval. Comparative studies with Fianlimab, however, have revealed that the latter has a higher objective response rate, fewer ≥3 adverse effects, and a lower rate of treatment discontinuation in patients due to adverse effects. In the middle of 2023, Regeneron plans to start a phase III study for Fianlimab in combination with Libtayo in the treatment of perioperative melanoma, and in the first half of 2023, it will start a phase II/III study for Fianlimab in combination with Libtayo in the first-line treatment of advanced NSCLC. For the second half of 2023, a phase II study on perioperative NSCLC has also been planned.
Another business, Shanghai, is developing a novel monoclonal antibody that targets LAG-3. Recombinant human monoclonal anti-LAG-3 antibody injection is its candidate HLX26. In a phase II clinical trial, the combination of HLX26 and HLX10, a humanised monoclonal antibody that targets PD-1, is being assessed. In this trial, patients with metastatic colorectal cancer who have already undergone three lines of therapy will be evaluated for the efficacy, safety, and tolerability of this anti-LAG-3/anti-PD-1 antibody combination.
Other candidates in phase II clinical studies are INCAGN02385 and LBL-007, which are being conducted by Incyte Biosciences and Leads Biolabs, respectively. Bispecific antibodies that target LAG-3 and another immune checkpoint protein like PD-1 and CTLA-4 were developed with the concept of co-blocking several immunological checkpoints. F-star Therapeutics, Xencor and EpimAb Biotherapeutics are now developing such bispecific antibodies. Nonetheless, monoclonal antibodies, which served as the foundation for the creation of bispecific antibodies, continue to dominate the clinical landscape.
The use of monoclonal antibodies in immunotherapy has had considerable clinical and economic success in recent years. This has spurred the creation of further monoclonal antibodies that target proteins that promote the growth of cancer. One such protein that has attracted attention for its immunosuppressive function in the body is LAG-3. In the next two to three years, Opdualag, the first and only LAG-3 inhibitor-containing medicine on the market, is expected to dominate sales. Opdualag, together with other advantageous market variables, will also drive the development of the clinical and research pipeline.