Novartis (NVS) announced that it had obtained Breakthrough Therapy Designation (BTD) for its drug capmatinib (INC280) to treat a specific subset of the NSCLC population. This program is in good shape, because the company is gearing up to file an NDA for approval for this drug in Q4 of 2019. Besides this specific population, there is another drug in Novartis’ pipeline which is also being explored for several types of NSCLC populations. With all these advancements, the company has a good shot at obtaining a large market share in the lung cancer space. Based on the progress for both of these programs, I believe Novartis is a buy.
Specific Subpopulation Of NSCLC That Is Hard To Treat
There are many treatments out there for NSCLC. Some are for a specific subpopulations, and others are for a more broad population. Well, Novartis’ capmatinib is being developed to treat metastatic MET exon 14 skipping mutated non-small cell lung cancer (NSCLC). This is not a very large population, only about 5.18% of NSCLC patients have this type of mutation. In essence, the MET gene is altered and drives mutation for this cancer type. There are a few MET inhibitors in clinical development. The one that Novartis has along with its partner Incyte (INCY), which is capmatinib. The other one is being developed by Merck KGaA (OTCPK:MKGAF), not to be confused with the other U.S. Merck (MRK). Merck KGaA’s drug is also a MET inhibitor drug known as tepotinib. The other item to note is that tepotinib was also granted Breakthrough Therapy Designation recently for the very same patient population. The thing is that this specific population, for the time being, has no targeted therapies approved by the FDA to treat these patients. Breakthrough Therapy Designation for capmatinib was given on the basis of positive data from the phase II GEOMETRY mono-1 study. The first thing to understand is that this study had several cohorts with different types of NSCLC populations. In terms of the MET mutation, one cohort (cohort 4) had recruited patients who had already received prior therapy with another drug. Then another cohort (cohort 5B) dealt with treatment naive patients. Treatment naive meaning first-line patients who had not yet received any prior therapy. These patients were given 400 mg of capmatinib two times a day. The primary endpoint was looking for overall response rate (ORR) per Blinded Independent Review Committee (BIRC) assessment per RECIST v1.1. It was noted that those in cohort 5B, who were treatment naive, had achieved a 68% ORR. On the other hand, those who had already been treated with another therapy in cohort 4, had achieved a 41% ORR. Capmatinib is good because it offers a more targeted approach for treatment, specifically for those NSCLC patients who have the MET exon 14 skipping mutation.
With Merck KGaA having its competing product, Tepotinib, it also had data as well. For its Vision study, it had achieved a 59% ORR in treatment naive patients and then 45% ORR for those who were previously treated. It seems that Novartis’ capmatinib saw a bit better efficacy. On the other hand, tepotinib had no grade 4 adverse events but capmatinib saw 4.5%. In addition, tepotinib produced fewer discontinuations of treatment. In my opinion, the difference in grade 4 adverse events and treatment discontinuation is not that large of gap. I also am not a big fan of cross-trial comparisons. That’s because there are so many other recruitment factors and criteria that one must take into account for a particular clinical outcome. Having said that, this gives a rough idea about a potential competitor and what data was achieved to date. Bottom-line, though, is that Novartis expects to file an NDA before the end of 2019, while Merck KGaA is still in the process of discussions with regulatory authorities.
Another Product In Pipeline May Be Useful for Lung Cancer Treatment
Besides capmatinib, Novartis is looking at other ways to target the lung cancer space. It is doing so with a subcutaneous treatment known as canakinumab. Canakinumab is an IL-1b inhibitor, which is a monoclonal antibody. This drug is being explored in several late-stage studies in the CANOPY program. These studies are:
- Canopy-A study – canakinumab as an adjuvant after complete surgical resection in stages II-IIIA non-small cell lung cancer (NSCLC) patients
- Canopy-1 study – canakinumab in combination with platinum-based chemotherapy and Keytruda (pembrolizumab) to treat patients with stage IIIB/IIC-IV squamous and non-squamous NSCLC
- Canopy-2 study – canakinumab or placebo plus docetaxel patients with stage IIIB-IV NSCLC patients previously treated with PD-1 or PD-L1 inhibitors, as well as platinum-based chemotherapy
The point here is that the CANOPY program is able to use canakinumab in multiple settings as an adjuvant or in combination with other standard of care therapies to treat patients with NSCLC. Also, canakinumab is not some type of investigational drug. It has already been approved by the FDA under the name ILARIS to treat several rare disease indications. In the most recent Q2 2019 earnings report, ILARIS generated $165 million in sales. It is in the top 20 products in Novartis’ portfolio in terms of sales. If Novartis can capitalize on eventually obtaining approval for one or more of these NSCLC indications, then sales of this drug should start to climb.
The fact that capmatinib was given Breakthrough Therapy Designation by the FDA for treating metastatic MET exon14 skipping mutated NSCLC patients is highly encouraging. That’s because the FDA will only give such a designation if two specific items are met. The first is that the treatment may offer substantial improvement over existing therapies. The second being that it must treat a serious or life-threatening disease. With both stipulations being met, the FDA has chosen to give capmatinib this status. The company believes that it can file an NDA for approval of capmatinib for this specific lung cancer patients population by Q4 of 2019. It is also in the process of discussing potential pathways to approval with other regulatory authorities around the globe. This is where the risk comes into play. The drug still has to pass through review in multiple regulatory agencies for approval. There is no guarantee that the drug will be approved. However, the company also has another drug in the pipeline known as ILARIS. This drug is being used in multiple trials to treat mid to late-stage NSCLC patients. This drug is another way in which Novartis can go after the lung cancer space. For all these reasons, I believe that the company will be good in the long term.
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