Recently, Gilead Sciences (GILD) announced results from its phase 1/2 trial using Yescarta to treat patients with refractory large B-cell lymphoma. These results were presented at the Annual Meeting of the American Society of Hematology (ASH) 2018 conference. A lot of patients have still obtained an impressive response rate at two years after a single infusion with Yescarta. Yescarta has shown to work well against this cancer, and hopefully, sales will start to pick up. The drug from Gilead has been doing okay in terms of sales but will need to see an improvement if it expects to hit blockbuster status.
Phase 1/2 Data
The data that was presented at the 2018 ASH medical meeting came specifically from the phase 1/2 ZUMA-1 study. The study was a single-arm study which treated 101 patients with refractory large B-cell lymphoma. One thing to note is that this was a two-year safety and efficacy follow-up of the patients. At two years, it was noted that at least 83% of these patients achieved an overall response rate (ORR). From those who obtained an ORR, it was noted that 58% achieved a complete response (CR). One key point from this follow-up is that at a median of 27.1 months, 39% of the patients remained with a response. Most notably out of all the data is that median overall survival (OS) has not yet been reached. I find that quite impressive, especially when you consider that these patients had already gone through two or more lines of systemic therapy. In addition, you have to consider how aggressive this cancer is for patients. When patients are treated with standard of care (SOC) therapy they have very poor outcomes.
Yescarta was launched back in October of 2017, and since then, it has been doing alright in sales. It has generated approximately $183 million in the first 9 months of being in the market. During the most recent Q3 2018 earnings for Gilead, it was announced that Yescarta generated $75 million in sales, which were up by 10% sequentially. Sales are growing at a moderate pace, but hopefully, they will start to pick up soon to potentially reach blockbuster status. What may help is the fact that Yescarta was approved in the European Union at the end of August of 2018. Gilead expects that it will possibly certify up to 20 centers by the end of 2018 in that region. This addition of centers could be another boost to get Yescarta sales going forward. Yescarta was the second gene therapy to be approved in the U.S. back on October 28, 2017. It was approved to treat patients with refractory large B-cell lymphoma. The sales should start to pick up, especially when you look at the current standard of care (SOC) treatments for refractory large B-cell lymphoma. Those treated with current SOC treatments obtain a median overall survival (OS) of approximately 6 months. About half of those patients who are taking second-line or later treatments do not respond or relapse when given a transplant. In other words, the approval of Yescarta opened up a significant treatment option for these patients.
The latest data highlights the potential that Yescarta has in this hard-to-treat refractory large B-cell lymphoma population. It is good to see that Yescarta was able to achieve such a strong overall response rate of 83% for these patients. This was achieved over a 2-year period, and the median overall survival has not yet been reached. The most notable item is that patients had already gone through 2 or more prior systemic therapies and didn't respond on those. However, it is encouraging to see such a strong overall response rate for these refractory large B-cell lymphoma patients was achieved over this long time period.
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