Pfizer Presents Overall Survival Data of XALKORI in Patients with ALK-Positive Advanced Non-Small Cell Lung Cancer

Longest Ever Follow-up Reported for Patients with Advanced ALK-positive NSCLC

NEW YORK, NY, USA I September 11, 2017 I Pfizer Inc. (NYSE:PFE) today announced final overall survival (OS) data from the PROFILE 1014 trial examining XALKORI® (crizotinib) in previously untreated patients with ALK-positive advanced non-small cell lung cancer(NSCLC). After a median follow-up of 46 months, the median OS for patients randomized to XALKORI was not reached (95% CI: 45.8 months, not reached) and was 47.5 months for patients randomized to chemotherapy (95% CI: 32.2 months, not reached). Results indicated a numerical improvement in OS for patients treated with first-line XALKORI compared with chemotherapy, though this difference did not quite achieve statistical significance (HR=0.760 [95% CI: 0.548, 1.053]; p=0.0978). These data [Abstract #LBA50] were presented today at the 2017 European Society for Medical Oncology (ESMO) Congress in Madrid, Spain.

The majority (84%) of patients initially randomized to chemotherapy received XALKORI after they progressed and this likely affected the overall survival results. A pre-specified, exploratory statistical analysis, adjusting for the effects of crossover, determined that median OS would have been longer for patients randomized to XALKORI than for patients randomized to chemotherapy, if patients had not been allowed to cross over [HR: 0.346 (95% CI: 0.081, 0.718)].

“PROFILE 1014 has provided important new data for patients with non-small cell lung cancer," said Professor Tony Mok, Chair of Department of Clinical Oncology, The Chinese University of Hong Kong. "This is the first set of prospective data from a randomized Phase 3 study to report long-term survival outcomes for patients with ALK-positive non-small cell lung cancer. The longest survival outcomes were in patients who received two or more tyrosine kinase inhibitors, which provides insight into optimal treatment sequencing.”

Overall survival was a secondary endpoint of PROFILE 1014 and the threshold for statistical significance was p≤0.0247.1 PROFILE 1014 was a global, randomized, open-label, two-arm Phase 3 study that evaluated the efficacy and safety of XALKORI in patients with previously untreated ALK-positive advanced NSCLC. Progression-free survival (PFS) was the primary endpoint, and these results were previously published in The New England Journal of Medicine (NEJM). There was a statistically significant improvement in PFS in the patients treated with XALKORI than with chemotherapy (p<0.001). A total of 343 patients were randomized into the trial, with approximately half of the patients in the XALKORI arm and the other half of the patients in the platinum doublet chemotherapy arm.

“XALKORI was the first biomarker-driven therapy for ALK-positive NSCLC and as such, dramatically changed the treatment paradigm for these patients. It remains the only ALK inhibitor with mature survival data from a randomized Phase 3 trial. We are extremely proud of the impact XALKORI continues to make on patients’ lives,” said Mace Rothenberg, MD, chief development officer, Oncology, Pfizer Global Product Development.

The most commonly reported adverse events with XALKORI were vision disorder (71%), diarrhea (61%), nausea (56%) and edema (49%), and with chemotherapy, nausea (59%), fatigue (38%), vomiting (36%) and decreased appetite (34%). Most adverse events in both treatment groups were grade 1 or 2 in severity. Grade 3 or 4 elevations of aminotransferase levels occurred in 14% of patients in the XALKORI group and 2% of patients in the chemotherapy group, and these elevations were managed primarily with dose interruptions or dose reductions. Grade 3 or 4 neutropenia occurred in 11% and 15% of patients in the XALKORI and chemotherapy groups, respectively, with no cases of febrile neutropenia reported with XALKORI and two cases with chemotherapy.

About Non-Small Cell Lung Cancer

Lung cancer is the leading cause of cancer death worldwide.2 NSCLC accounts for about 85 percent of lung cancer cases and remains difficult-to-treat, particularly in the metastatic setting.3 Approximately 75 percent of NSCLC patients are diagnosed late with metastatic, or advanced, disease where the five-year survival rate is only 5 percent.3,4,5

About XALKORI® (crizotinib)

XALKORI is a tyrosine kinase inhibitor indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved test. XALKORI has received approval for patients with ALK-positive NSCLC in more than 90 countries6 including Australia, Canada, China, Japan, South Korea and the European Union.

About Pfizer Oncology

Pfizer Oncology is committed to pursuing innovative treatments that have a meaningful impact on those living with cancer. As a leader in oncology speeding cures and accessible breakthrough medicines to patients, Pfizer Oncology is helping to redefine life with cancer. Our strong pipeline of biologics, small molecules and immunotherapies, one of the most robust in the industry, is studied with precise focus on identifying and translating the best scientific breakthroughs into clinical application for patients across a wide range of cancers. By working collaboratively with academic institutions, individual researchers, cooperative research groups, governments and licensing partners, Pfizer Oncology strives to cure or control cancer with its breakthrough medicines. Because Pfizer Oncology knows that success in oncology is not measured solely by the medicines you manufacture, but rather by the meaningful partnerships you make to have a more positive impact on people’s lives.

Working together for a healthier world®

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_NewsLinkedIn, YouTube, and like us on Facebook at Facebook.com/Pfizer.

1 Solomon B., Mok T. et al. First-Line Crizotinib versus Chemotherapy in ALK-Positive Lung Cancer. N Engl J Med. 2014; 371:2167-2177. December 4, 2014DOI: 10.1056/NEJMoa1408440.

2 The International Agency for Research on Cancer, the World Health Organization, GLOBOCAN 2008, Available at: http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx (select “Lung” from the drop-down menu). Accessed October 31, 2014.

3 Reade CA, Ganti AK. EGFR targeted therapy in non-small cell lung cancer: potential role of cetuximab. Biologics. 2009; 3: 215–224.

4 Yang P, Allen MS, Aubry MC, et al. Clinical features of 5,628 primary lung cancer patients: experience at Mayo Clinic from 1997 to 2003. Chest. 2005;128(1):452–462

5 American Cancer Society. Detailed Guide: Lung Cancer (Non-Small Cell). Available at: http://www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/non-small-cell-lung-cancer-survival-rates. Accessed October 31, 2014.

6 Pfizer data on file.

SOURCE: Pfizer

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