Recently, AbbVie (ABBV) and its partner Johnson & Johnson (JNJ) announced strong results from its long-term studies using its cancer drug Imbruvica. This study was an important one because they were seven-year follow up studies for these patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). This study was important because it highlighted how well Imbruvica could perform alone as a monotherapy over a seven-year period. The final positive outcome was established in both first-line patients and those with relapsed/refractory forms of the cancer.
Phase 1b/2 Data
The long-term seven-year follow-up results from AbbVie consisted of two studies. They were PCYC-1102 and PCYC-1103, respectively. These trials recruited a total of 132 newly diagnosed (first-line) and r/r CLL/SLL patients who were monitored over a seven-year period. For the entire time patients were only given Imbruvica as a monotherapy. It was reported that there was an overall response rate of 89% for all patients. Such ORR also were seen in 87% of previously untreated patients and in 89% in r/r patients. What is also noteworthy is that median duration of response (mDOR), median progression-free survival (NYSE:PFS), nor median overall survival were yet reached. Newly diagnosed patients have thus far have achieved an estimated seven-year overall survival (OS) rate of 75%. Those who are relapsed/refractory have reached an estimated seven-year overall survival rate of 52%. This data is highly impressive, especially when you consider the fact that Imbruvica was only given as a monotherapy. This data reinforces Imbruvica as a powerful drug at physicians disposal to treat these CLL/SL patient populations. In my opinion, the data above shows Imbruvica as being a tolerable yet effective option at curbing cancer over a prolonged period of time.
Chronic Lymphocytic Leukemia Population
Chronic lymphocytic Leukemia (CLL) develops from a white blood cell called a B-cell. It starts to progress slowly at first, and it typically affects older patients. The big problem with the disease is that symptoms take years to develop for this cancer. Once symptoms show they are particular ones like swollen lymph nodes and easy bruising. Typical treatments may be stem-cell transplants, which are only used in aggressive cases. Chemotherapy is typically used, but that also has a lot of issues of its own such as toxicity for the patient. Imbruvica is likely better in terms of safety, and after the seven-year study results appear to offer a better long-term treatment outcome. The best part of all about the latest Imbruvica results is that it appears as though patients are living longer than previously expected. Remember, this is an aggressive type of cancer. Therefore, there's an increased risk in mortality for these patients. However, treatment with Imbruvica seemed to work better than previously expected. In other words, such a long-term outcome for this patient population was not expected.
Imbruvica has been doing fairly well in the market for many years now. This past third quarter earnings report was no different. It was reported by AbbVie that global net revenues for Imbruvica were $972 million. This was split up with U.S. sales coming in at $812 million, while the international profit sharing was at $160 million. The reason why I state that Imbruvica continues to be strong in sales is because it continues to grow at a rate of 41.3%. Sales continue to come in strong for Imbruvica. The long-term studies, in essence, reinforce the notion that monotherapy treatment with Imbruvica is a more solid treatment option for patients compared to many other forms of treatment. The latest long-term results, over a seven-year period, reinforce the efficacy observed with Imbruvica as a monotherapy. The long-term effect of Imbruvica was observed in both first-line patients and those with relapsed/refractory form of the cancer.
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 deep dive analysis of many pharmaceutical companies. Come see for yourself if my service is right for you. 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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