On Sunday morning, 9 AM Eastern Daylight Time in the US, Clovis Oncology, Inc. (CLVS) reported a host of updated results for its non-small cell lung cancer treatment rociletinib. The data, reported as “consistent and promising” comes just 24 hours after the announcing of even more promising updates from the company’s concurrent phase 2 study of Rucaparib in treating ovarian cancer. Both announcements are likely to translate to some upside momentum in Clovis stock and so, with this said, what are the treatments in question, and what could it mean for Clovis going forward?
First, let’s take a look at the treatments themselves.
Rucaparib is an oral treatment designed to inhibit a protein called poly (ADP-ribose) polymerase (“PARP”). When cells divide – both tumor and normal cells – the DNA of those cells must replicate correctly or the cell will die. Oftentimes there occur breaks in these cells during replication, but in a normal situation, the body will repair these breaks and the process will continue as normal. The PARP protein plays a key role in one of two primary methods used in the body to repair these DNA breaks. Using a biomarker test, Clovis identifies ovarian cancer tumor cells that are sensitive to PARP inhibition, and the treatment targets these cells. Essentially, the drug stops the body from repairing DNA breaks that occur during cell replication for ovarian cancer cells, and in turn, slows or stops the growth of tumors.
The other treatment is Rociletinib. Rociletinib is designed to inhibit protein called epidermal growth factor receptor (EGFR). When EGFR activates on cancer cells, it signals the cancer cells to grow and replicate. When taken orally by a specific type of lung cancer patients (those with EGFR mutation-positive non–small cell lung cancer) Clovis believes that Rociletinib blocks the EGFR signaling and – in turn – halts or reduces replication of cancer cells.
With that out of the way, what did the results that Clovis released over the weekend show?
First let’s look at Rucaparib. In the treatment of platinum sensitive BRCA-mutant ovarian cancer patients, we saw an overall response rate of 82%, disease control at 94%, and a medium progression free survival of 9.4 months. We also saw a 10% complete response rate, as well as a manageable safety profile and the suggestion that the drug is well tolerated, with only mild adverse events including anemia, fatigue, and nausea. This is great news for Clovis, and Patrick J. Mahaffy, President and CEO of Clovis Oncology had this to say upon its release:
“With these data presented at ASCO, we believe rucaparib has clearly emerged as a unique and best-in-class PARP inhibitor”.
Now let’s look at Rociletinib. In this instance we saw a 60% overall response rate and the 90% of these control rate in very advanced patients with EGFR mutant non-small cell lung cancer. Medium progression free survival totaled 10.3 months in patients without history of metastases and 40% of those with a history of metastases. While these results are not quite as exciting as those demonstrated by the previously mentioned Rucaparib, this still indicate efficacy and could be enough to give us some bullish momentum in Clovis stock this week.
What is the potential market impact of these two drugs being approved for Clovis? According to the National Cancer Institute, nearly 230,000 Americans are diagnosed with lung cancer each year. About 80% of these diagnoses will be non-small cell lung cancers, and about 10% of these will be EGFR gene mutated. This means the US market is just short of 20,000 patients every year. In the US, average treatment costs for lung cancer come in around $60,000, meaning the industry is a $1 billion industry. Obviously, this number includes all treatment expenses, but it gives an idea of where the market fits in terms of size.
Looking at ovarian cancer, the total market for a varying cancer in the US, Europe and Japan combined is about $460 million at the moment. Analysts forecast that this will increase to US$1.4 billion by 2021. BRCA mutations occur in about 10% of total cases, which – at a rough estimate – will put the global markets around $140 million.
So, with all this said, what are takeaways? Well, markets will likely respond positively to this data, especially the Rucaparib results. An 82% response rate is impressive, and if the company can report similar trial completion results, we could see some serious upside as we head into phase 3 and beyond.