Despite all the treatment we have and particularly the new immunotherapy, the monoclonal antibodies, CD38 we spoke about, but also the BCMA, FCRH5, GPRC5D, bispecifics, the CAR-T, whatever. Whatever the immunotherapy we have, most of the patients do relapse. Most of the patients will get to a point, to a situation where they have been receiving all treatments and either the disease is refractory or they can’t tolerate the treatments anymore...
Despite all the treatment we have and particularly the new immunotherapy, the monoclonal antibodies, CD38 we spoke about, but also the BCMA, FCRH5, GPRC5D, bispecifics, the CAR-T, whatever. Whatever the immunotherapy we have, most of the patients do relapse. Most of the patients will get to a point, to a situation where they have been receiving all treatments and either the disease is refractory or they can’t tolerate the treatments anymore. And so we always need new treatments for these patients. This group of patients is shrinking over time, years after years, but there’s still a lot of patients in the world that face that terrible situation.
There has been a new target of great interest, BCMA, B-cell maturation antigen. And the first drug developed to target that BCMA receptor on the tumor cells was actually an ADC, antibody-drug conjugate. We hear a lot about the CAR-T and the bispecific, but the first drug developed was actually an ADC, the belantamab mafodotin. And so the belantamab fixes to the BCMA and the mafodotin is a chemical compound that goes into the cells to destroy the tumor cells. Belantamab mafodotin was first used in end-stage myeloma, palliative care patients that have failed almost all existing treatments, to demonstrate that if it could work there and be safe enough, then it would probably work much earlier in the line of treatment.
And so the pharma company GSK has developed a series of studies in the end-stage myeloma to demonstrate the potential power of that drug, and the dose, the regimen, how to give it, how safe it is, what could be the issues that the patient should be knowing and dealing with. And then after that, the next step was to demonstrate that now, taken out of clinical trials, but used in the real life, all the different groups, subpopulations of patients that are part of the real life but may not be represented into the clinical trials, because it’s hard to treat a patient into the clinical trials. There are specific criteria to get in. All these real-life subpopulations would benefit from that treatment to the same extent as the study in clinical trials.
And so we have published the ALFA study, which is a retrospective analysis, retro and prospective analysis of the use of belantamab mafodotin in the end-stage very advanced myeloma in the real life in France, in the context of the compassionate use of this drug, belantamab mafodotin, Blenrep. And so we found out that actually we were absolutely capable of replicating what we have seen in the clinical trials. I would say even better, because we have rapidly used the drug in lesser, very advanced patients, where we immediately saw that it was quite effective. The median PFS in the population that benefited most from the treatment was around 20 months, which is very, very good. We also learned how to give that drug to the patients and manage a safety profile. We experienced what we know of the belantamab mafodotin today, which is essentially one important side effect, the keratopathy, the corneal toxicity, the keratopathy. And we found out that in real life, when you get experienced with a drug, whether you get experience with managing this keratopathy, it was possible to maintain the patient on treatment, to find the right schedule for a given patient to maintain that patient on treatment and so to allow the patients to continue in their benefit of the treatment and their survival brought by their treatment.
So the ALFA study now is one among many real life studies that have confirmed belantamab was a great drug for myeloma and BCMA target a key target in myeloma, that belantamab was capable of saving patients in end-stage myeloma from dying. There is one safety profile to know if you use belantamab which is the keratopathy, but we’re confident we can manage it and we can help the patient maintain on treatment and benefit from that treatment.
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