Sanofi (SNY) announced that it had received FDA approval for its cancer drug Sarclisa in a combination regimen treating patients with relapsed/refractory multiple myeloma. This cancer drug is expected to be launched in the U.S. in the near term and it will be a big win for the company. That’s because it will be the first in-house developed cancer drug to make it through the finish line with FDA approval in a decade. In-house meaning the drug was developed internally with its very own R&D. Not partnered out or licensed from another pharmaceutical company.
The thing is that it won’t have all the market to itself, because it will have to go up against Johnson & Johnson (JNJ) with its cancer drug Darzalex. That’s because both of these drugs target the same patient population. In addition, they both use the very same type of mechanism of action when it comes to the drugs they use to treat these patients. However, in the end, it is good to see that Sanofi is able to get its R&D in order to get a win such as this.
FDA Approval Of Sarclisa Brings Oncology R&D Back Into Fold
The FDA had approved Sarclisa in combination with pomalidomide and dexamethasone (POM-DEX) for the treatment of adults with relapsed/refractory multiple myeloma (MM). These were MM patients who were in dire shape, because they had received at least two prior therapies before entering this study, including those who had failed on lenalidomide and a proteasome inhibitor.
Sarclisa is a monoclonal antibody which binds to the CD38 receptor found on MM cells. The FDA approval of Sarclisa was because of highly positive data which stemmed from the ICARIA-MM study. In this study, Sarclisa had excellent synergy when combined with pomalidomide and dexamethasone. There was a statistically significant improvement in both:
- Progression-free survival (PFS)
- Overall response rate (ORR)
In terms of progression-free survival, patients treated with the Sarclisa combination had a median PFS of 11.53 months. This compares to the combination of pomalidomide and dexamethasone alone with only 6.47 months. That is, the Sarclisa combination significantly reduced the risk of disease progression or death by 40% compared to POM-DEX. This gave a statistically significant p-value of p=0.0010. A huge difference was also achieved in terms of the overall response rate.
With respect to the overall response rate, that was superior also. Patients treated with the Sarclisa combination achieved an overall response rate of 60.4%, compared to only 35.3% for those on pomalidomide and dexamethasone alone. This FDA approval was for 3rd-line treatment, but the entire program for Sarclisa is ongoing. It is already being explored in studies to target other populations within MM, several other hematological malignancies and even solid tumors.
Market Opportunity Solid But Competition Remains In place
Multiple Myeloma (MM) is a cancer of plasma cells. These plasma cells are white blood cells that are found in the bone marrow. The thing is that these plasma cells end up becoming cancerous and multiply in the patient’s body. In turn, patients experience damage in several parts of the body like:
- Red Blood cells
- Immune System
MM is the second most common type of blood cancer. It is estimated that about 32,000 people in the United States are diagnosed with it. The global MM treatment market is estimated to be worth $50.5 billion by 2025. The thing is that there are already several competitors in place, which makes it a tough market to conquer. One of the main competitors in the space is Bristol-Myers Squibb (BMY) with Revlimid. This drug has been approved for several blood cancer indications, but quite a few labels with respect to MM. Still a major competitor down the line. What makes MM a burden is that patients either relapse or become refractory to their current treatment. As such, it is important to have treatments that can be used as a 3rd line option.
A similar therapy, which comes as a competing drug against Sarclisa would be Darzalex from Johnson & Johnson. Darzalex, like Sarclisa, is also a CD38 inhibitor. It has been approved for six-plus indications for the treatment of patients with MM. Darzalex is a direct competitor with Sarclisa, because it has been approved as a 3rd-line treatment option for MM patients as well. Specifically, Darzalex in combination with POM-DEX (Pomalidomide – Dexamethasone) was approved to treat MM patients who had failed at least two prior therapies, which include POM-DEX. Again, this was regulatory approval for 3rd-line treatment option for MM patients. The use of CD38 inhibitors is to specifically target white blood cells in the bone marrow that are responsible for causing MM. Being that these white blood cells have CD38 on their surface, therapies like Sarclisa and Darzalex are ideal for these patients.
Risks To Business
The biggest risk for Sarclisa would be the competitive landscape in place for MM. As I noted above, there are several MM drugs that have been doing well on the market. The direct competitor would be Johnson & Johnson with Darzalex, because it is also a CD38 inhibitor. This then goes to the next risk, which is commercial uptake. It will be important to see if sales can live up to expectations. It is expected that Sarclisa, for the 3rd-line MM market, could bring in $3.4 billion for the company.
The second-line market is expected to be even bigger than that estimate. Key execution of the commercial launch for Sarclisa and getting the drug to patients will be closely watched. What will also help is that an application for Europe, seeking approval for Sarclisa in combination with POM-DEX for this patient population, had already been submitted back in Q2 of 2019. This means 2020 brings about potential European marketing approval for this same patient population also.
Sanofi has been able to see success again in its R&D with respect to the oncology business. The FDA approval of Sarclisa is a good step in the right direction for this part of the business. The last approval for a cancer drug that was developed in house by Sanofi itself was Jevtana. Jevtana was approved by the FDA back in June 17, 2010 for the treatment of patients with hormone-refractory prostate cancer. This is only the beginning for the company, as I noted above. That’s because it is looking at targeting front-line/second-line MM patients using Sarclisa. In addition, to expand the program to go after other hematological malignancies and solid tumors. If success is achieved in these other key areas for Sarclisa, that would be a huge deal for the company. This was a big win for Sanofi.
This article is published by Terry Chrisomalis, who runs the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace. If you like what you read here and would like to subscribe to, I’m currently offering a two-week free trial period for subscribers to take advantage of. My service offers a deep-dive analysis of many pharmaceutical companies. The Biotech Analysis Central SA marketplace is $49 per month, but for those who sign up for the yearly plan will be able to take advantage of a 33.50% discount price of $399 per year.
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