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New Crizotinib Results Show Positive Outcomes

Anita T. Shaffer @Shaffer1
Published: Friday, Jul 08, 2011

Fiona Blackhall, MD, PhD
Fiona Blackhall, MD, PhD
Crizotinib, an oral compound that blocks signaling in cell pathways, demonstrated marked antitumor activity among patients with advanced ALK-positive non–small cell lung cancer (NSCLC) in fresh data released this week at the 14th World Conference on Lung Cancer in Amsterdam, The Netherlands.

Early phase II results from the PROFILE 1005 trial indicate that 51% of 133 patients treated with crizotinib exhibited an overall response, including 1 patient who experienced a complete response, according to Pfizer Inc, which is developing the drug.

At 12 weeks, the disease control rate was 74%, meaning that a proportion of participants achieved stable disease, or partial or complete responses.

Participants in the single-arm, open-label trial had undergone prior chemotherapy, and their tumors had tested positive for the ALK fusion gene, whose mutations are believed to be a key driver in lung cancer. Crizotinib inhibits ALK, or anaplastic lymphoma kinase.

“These findings are significant in showing that symptoms due to lung cancer can be alleviated by crizotinib, and so they support ongoing development,” said research scientist Fiona Blackhall, MD, PhD, in an email interview with OncLive.com.

Blackhall, a consultant medical oncologist and honorary senior lecturer at The Christie Hospital NHS Foundation Trust and Manchester Cancer Research Centre, United Kingdom, is part of an international research team studying the drug.

“Crizotinib is promising for patients with NSCLC bearing ALK gene rearrangement,” she said.  “It appears to be well tolerated, has demonstrated anticancer activity with a response rate of 51%, and has been shown to improve patient-reported outcomes, including cough, pain, and shortness of breath.”

Overall, the most common adverse events (AEs) reported in the trial were grade 1/2 gastrointestinal toxicities such as nausea (57%), vomiting (43%), and diarrhea (43%).

Twenty-four percent of patients experienced ≥3 AEs, particularly fatigue (2%) and increased alanine aminotransferase (7%).  There were 2 treatment-related deaths during the study; 1 death is attributed to pneumonitis confounded by prior treatment and medical history while the cause of the other death is unknown.

In a companion study, patient-reported outcomes indicated an improvement of ≥10 points in key symptoms such as pain, dyspnea, fatigue, cough, insomnia, and loss of appetite.

Lung cancer symptoms such as cough and shortness of breath are difficult to improve with supportive care alone. ”
–Fiona Blackhall, MD, PhD
Blackhall noted the need to alleviate the discomfort of patients with advanced NSCLC.

“Lung cancer symptoms such as cough and shortness of breath are difficult to improve with supportive care alone,” she said. “Treatment to tackle these symptoms is of great importance to patients.”

NSCLC is the most prevalent form of lung cancer, which itself is the leading cause of cancer death among men and women in the United States, according to the American Cancer Society. Approximately 3% to 5% of NSCLC tumors are ALK-positive, Pfizer said.

In January, Pfizer announced the rolling submission of a new drug application to the FDA under the agency’s fast-track process. Last month, key research about crizotinib presented at the American Society of Clinical Oncology annual meeting in Chicago, Illinois, indicated that ALK-positive patients who received the drug demonstrated higher overall survival rates than study participants who did not.

Blackhall said the latest data build upon those findings.


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