Alecensa (alectinib) is an FDA-approved therapy for the treatment of ALK-positive metastatic (advanced) non-small cell lung cancer (NSCLC). The drug was developed by Chugai Pharmaceuticals, part of the Roche Group. Outside of Japan, it is marketed by Genentech (another member of the Roche Group).

How Alecensa works

Around 5 percent of NSCLC tumors are “ALK-positive.” This is more common in nonsmokers and can be associated with an increased risk of the cancer spreading to the brain.

These tumors have a chromosomal rearrangement (an abnormality where large sections of DNA have been swapped around) in the anaplastic lymphoma kinase (ALK) gene, resulting in the formation of a “fusion protein”. A fusion protein contains a part of one or more proteins joined together.

In adults, ALK is normally only found in the brain, but the chromosomal rearrangement causes the protein to be wrongly expressed in the cancerous tissue. ALK then sends signals to promote uncontrolled growth leading to the survival of the cancer cells.

Alecensa targets and blocks ALK from working in cancer cells. This helps stop the growth of the tumor and induce cancer cell death, reducing the size of the tumor. In particular, Alecensa is effective against lung cancer tumors that have spread to the brain (brain metastases).

Alecensa in clinical trials

Alecensa was initially approved by the U.S. Food and Drug Administration (FDA) in December 2015, for the treatment of ALK-positive NSCLC following treatment with Xalkori (crizotinib). The drug also received conditional approval from the European Medicines Agency (EMA) in February 2017. However, further evidence from ongoing clinical trials is needed to maintain this status.

The approval was based on two key Phase 1/2 clinical studies, the NP28673 (NCT01801111) and the NP28761 (NCT01871805) studies, on a total of 225 participants. The results of these studies were discussed in three separate reports published in The Lancet OncologyAnnals of Oncology, and The Journal of Clinical Oncology. The results were positive overall, as participants in both studies had their tumors shrink by 48 percent (NP28673) and 69 percent (NP28761). These trials were not placebo-controlled.

On Oct. 2, 2016, Alecensa was granted breakthrough therapy designation by the FDA to help speed up the development and review of the drug as a first-line treatment for ALK-positive NSCLC.

This designation was based on the results of a Phase 3 clinical trial called J-ALEX  (JapicCTI-132316), which have now been published in the scientific journal The Lancet. This study compared the efficacy and safety of Alecensa to Xalkori in 207 Japanese participants and demonstrated that Alecensa significantly prolonged progression-free survival (PFS) compared to Xalkori.

The study is still ongoing as a larger, worldwide Phase 3 trial called ALEX (NCT02075840). The results released so far are promising: Alecensa increased PFS by 53 percent compared to Xalkori and reduced the risk of disease progression in the brain and spinal cord by 84 percent. Furthermore, serious adverse effects were less common in participants taking Alecensa compared to Xalkori.

Other information

The most common side effects experienced by patients treated with Alecensa are fatigue, constipation, edema, muscle pain, cough, rash, nausea, headache, diarrhea, difficulty breathing, back pain, vomiting, weight gain, and vision problems.

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