NEW YORK, NY, USA I April 03, 2019 I Pfizer Inc. (NYSE: PFE) today announced that the European Commission has approved VIZIMPRO® (dacomitinib), a tyrosine kinase inhibitor (TKI), as monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations.
“Lung cancer remains the leading cause of cancer-related death worldwide and despite advances in biomarker-driven therapies, overcoming resistance continues to be crucial in treating EGFR-mutated non-small cell lung cancer,” said Andreas Penk, M.D., regional president, Oncology International Developed Markets at Pfizer. “The marketing authorization of VIZIMPRO, which has shown a more than five-month improvement in progression-free survival over an existing therapy in a Phase 3 clinical trial, provides a new option for patients with EGFR-mutated non-small cell lung cancer and reinforces Pfizer’s ongoing commitment to addressing the remaining needs of the thousands of EU patients with this disease.”
The European Commission’s approval of VIZIMPRO was supported by data from ARCHER 1050, a randomized, multicenter, multinational, open-label, Phase 3 study conducted in patients with unresectable, metastatic or recurrent NSCLC harboring EGFR exon 19 deletion or exon 21 L858R substitution mutations. A total of 452 patients were randomized 1:1 to VIZIMPRO 45 mg (n=227) or gefitinib 250 mg (n=225). The primary endpoint was progression-free survival (PFS) as determined by blinded Independent Radiologic Central (IRC) review. Key secondary endpoints included PFS assessed by the investigator, objective response rate (ORR), duration of response (DoR) and overall survival (OS).
A statistically significant improvement in PFS as determined by the IRC was demonstrated for patients randomized to VIZIMPRO compared with gefitinib (HR = 0.59 [95% CI: 0.47, 0.74], p <0.0001). Median PFS in the VIZIMPRO group was 14.7 months (95% CI: 11.1, 16.6) compared with 9.2 months (95% CI: 9.1, 11.0) in the gefitinib arm.
“Over the last two decades, biomarker-driven therapies have become standard-of-care for patients with EGFR-mutated non-small cell lung cancer,” said Dr. Federico Cappuzzo, Director of Oncology and Hematology Department AUSL della Romagna-Ravenna. “The improvement in progression-free survival for VIZIMPRO over a first-generation standard-of-care therapy in the ARCHER 1050 study is impressive, and I’m pleased it will be available for appropriate patients with non-small cell lung cancer in the EU.”
OS results from the final analysis (data cut-off date of 17-Feb-2017) performed when 48.7 percent of events had occurred, showed a gain of 7.3 months in median OS for patients treated with VIZIMPRO compared to those treated with gefitinib (34.1 months vs. 26.8 months; HR: 0.760 [95% CI: 0.582, 0.993]). However, the statistical significance of the OS improvement could not formally be assessed, as the secondary endpoints from the study were tested in descending order of perceived importance and stopped when no additional statistical significance of ORR was reached.
Among 227 patients with EGFR-mutated metastatic NSCLC who received VIZIMPRO in ARCHER 1050, the most common (≥ 20%) adverse reactions were diarrhea (87%), rash (77%), stomatitis (70%), nail disorder (66%), decreased appetite (31%), dry skin (30%), weight decreased (26%), transaminases increased (24%), conjunctivitis (23%), alopecia (23%), and pruritus (20%). Serious adverse reactions occurred in 6.2 percent of patients treated with VIZIMPRO. The most common (≥ 1%) serious adverse reactions reported were diarrhea (2.2%) and interstitial lung disease (1.3%).1,2
About VIZIMPRO® (dacomitinib), 45 mg, 30 mg and 15 mg tablets
VIZIMPRO is an oral, once-daily, irreversible pan-human epidermal growth factor receptor kinase inhibitor. VIZIMPRO is approved in the EU for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations.
VIZIMPRO is also approved in the United States for the first-line treatment of patients with metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. Additionally, VIZIMPRO is approved in Japan for EGFR gene mutation-positive, inoperable or recurrent NSCLC, and in Canada for the first-line treatment of adult patients with unresectable locally advanced or metastatic NSCLC with confirmed EGFR exon 19 deletion or exon 21 L858R substitution mutations. The applications in the US and Japan were reviewed and approved under the Priority Review program.
In 2012, Pfizer and SFJ Pharmaceuticals entered into a collaborative development agreement to conduct ARCHER 1050 across multiple sites. SFJ is a global drug development company, which provides a unique and highly customized co-development partnering model for the world’s top pharmaceutical and biotechnology companies. Under the terms of this agreement, SFJ Pharmaceuticals provided the funding and conducted the trial to generate the clinical data used to support this application. Pfizer retains all rights to commercialize VIZIMPRO globally.
About ARCHER 1050
The efficacy of VIZIMPRO was demonstrated in ARCHER 1050, a global Phase 3 head-to-head trial conducted in patients with unresectable, metastatic or recurrent non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations, with no prior therapy for metastatic disease or recurrent disease with a minimum of 12 months disease-free after completion of systemic therapy. A total of 452 patients were randomized 1:1 to VIZIMPRO 45 mg (n=227) or gefitinib 250 mg (n=225). Randomization was stratified by region and EGFR mutation status. The primary endpoint of the study was progression-free survival (PFS) as determined by blinded Independent Radiology Central (IRC) review. Key secondary endpoints included PFS assessed by the investigator, objective response rate (ORR), duration of response (DoR), overall survival (OS), and patient-reported outcomes (PROs).
About Pfizer in Lung Cancer
Pfizer Oncology is committed to addressing the unmet needs of patients with lung cancer, the leading cause of cancer-related deaths worldwide and a particularly difficult-to-treat disease. Pfizer strives to address the diverse and evolving needs of patients with non-small cell lung cancer (NSCLC) by developing efficacious and tolerable therapies, including biomarker-driven therapies and immuno-oncology (IO) agents and combinations. By combining leading scientific insights with a patient-centric approach, Pfizer is continually advancing its work to match the right patient with the right medicine at the right time. Through our growing research pipeline and collaboration efforts, we are committed to delivering renewed hope to patients living with NSCLC.
About Pfizer Oncology
At Pfizer Oncology, we are committed to advancing medicines wherever we believe we can make a meaningful difference on the lives of patients. Today, Pfizer Oncology has an industry-leading portfolio of 18 approved innovative cancer medicines and biosimilars across more than 20 indications, including breast, prostate, kidney, lung and hematology. Pfizer Oncology is striving to change the trajectory of cancer.
Pfizer Inc: 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_News, LinkedIn, YouTube, and like us on Facebook at Facebook.com/Pfizer.
| 1 VIZIMPRO® (dacomitinib). Summary of Product Characteristics.] |
| 2 Pfizer. Data on File. |
| 3 Lovly CM, Horn L. Molecular profiling of lung cancer. My Cancer Genome; 2016. https://www.mycancergenome.org/content/disease/lung-cancer/. Accessed January 2019. |
| 4 Pao W, Miller VA. Epidermal growth factor receptor mutations, small-molecule kinase inhibitors, and non-small-cell lung cancer: current knowledge and future directions. J Clin Oncol. 2005;23:2556-2568. |
SOURCE: Pfizer
Post Views: 30
NEW YORK, NY, USA I April 03, 2019 I Pfizer Inc. (NYSE: PFE) today announced that the European Commission has approved VIZIMPRO® (dacomitinib), a tyrosine kinase inhibitor (TKI), as monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations.
“Lung cancer remains the leading cause of cancer-related death worldwide and despite advances in biomarker-driven therapies, overcoming resistance continues to be crucial in treating EGFR-mutated non-small cell lung cancer,” said Andreas Penk, M.D., regional president, Oncology International Developed Markets at Pfizer. “The marketing authorization of VIZIMPRO, which has shown a more than five-month improvement in progression-free survival over an existing therapy in a Phase 3 clinical trial, provides a new option for patients with EGFR-mutated non-small cell lung cancer and reinforces Pfizer’s ongoing commitment to addressing the remaining needs of the thousands of EU patients with this disease.”
The European Commission’s approval of VIZIMPRO was supported by data from ARCHER 1050, a randomized, multicenter, multinational, open-label, Phase 3 study conducted in patients with unresectable, metastatic or recurrent NSCLC harboring EGFR exon 19 deletion or exon 21 L858R substitution mutations. A total of 452 patients were randomized 1:1 to VIZIMPRO 45 mg (n=227) or gefitinib 250 mg (n=225). The primary endpoint was progression-free survival (PFS) as determined by blinded Independent Radiologic Central (IRC) review. Key secondary endpoints included PFS assessed by the investigator, objective response rate (ORR), duration of response (DoR) and overall survival (OS).
A statistically significant improvement in PFS as determined by the IRC was demonstrated for patients randomized to VIZIMPRO compared with gefitinib (HR = 0.59 [95% CI: 0.47, 0.74], p <0.0001). Median PFS in the VIZIMPRO group was 14.7 months (95% CI: 11.1, 16.6) compared with 9.2 months (95% CI: 9.1, 11.0) in the gefitinib arm.
“Over the last two decades, biomarker-driven therapies have become standard-of-care for patients with EGFR-mutated non-small cell lung cancer,” said Dr. Federico Cappuzzo, Director of Oncology and Hematology Department AUSL della Romagna-Ravenna. “The improvement in progression-free survival for VIZIMPRO over a first-generation standard-of-care therapy in the ARCHER 1050 study is impressive, and I’m pleased it will be available for appropriate patients with non-small cell lung cancer in the EU.”
OS results from the final analysis (data cut-off date of 17-Feb-2017) performed when 48.7 percent of events had occurred, showed a gain of 7.3 months in median OS for patients treated with VIZIMPRO compared to those treated with gefitinib (34.1 months vs. 26.8 months; HR: 0.760 [95% CI: 0.582, 0.993]). However, the statistical significance of the OS improvement could not formally be assessed, as the secondary endpoints from the study were tested in descending order of perceived importance and stopped when no additional statistical significance of ORR was reached.
Among 227 patients with EGFR-mutated metastatic NSCLC who received VIZIMPRO in ARCHER 1050, the most common (≥ 20%) adverse reactions were diarrhea (87%), rash (77%), stomatitis (70%), nail disorder (66%), decreased appetite (31%), dry skin (30%), weight decreased (26%), transaminases increased (24%), conjunctivitis (23%), alopecia (23%), and pruritus (20%). Serious adverse reactions occurred in 6.2 percent of patients treated with VIZIMPRO. The most common (≥ 1%) serious adverse reactions reported were diarrhea (2.2%) and interstitial lung disease (1.3%).1,2
About VIZIMPRO® (dacomitinib), 45 mg, 30 mg and 15 mg tablets
VIZIMPRO is an oral, once-daily, irreversible pan-human epidermal growth factor receptor kinase inhibitor. VIZIMPRO is approved in the EU for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations.
VIZIMPRO is also approved in the United States for the first-line treatment of patients with metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. Additionally, VIZIMPRO is approved in Japan for EGFR gene mutation-positive, inoperable or recurrent NSCLC, and in Canada for the first-line treatment of adult patients with unresectable locally advanced or metastatic NSCLC with confirmed EGFR exon 19 deletion or exon 21 L858R substitution mutations. The applications in the US and Japan were reviewed and approved under the Priority Review program.
In 2012, Pfizer and SFJ Pharmaceuticals entered into a collaborative development agreement to conduct ARCHER 1050 across multiple sites. SFJ is a global drug development company, which provides a unique and highly customized co-development partnering model for the world’s top pharmaceutical and biotechnology companies. Under the terms of this agreement, SFJ Pharmaceuticals provided the funding and conducted the trial to generate the clinical data used to support this application. Pfizer retains all rights to commercialize VIZIMPRO globally.
About ARCHER 1050
The efficacy of VIZIMPRO was demonstrated in ARCHER 1050, a global Phase 3 head-to-head trial conducted in patients with unresectable, metastatic or recurrent non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations, with no prior therapy for metastatic disease or recurrent disease with a minimum of 12 months disease-free after completion of systemic therapy. A total of 452 patients were randomized 1:1 to VIZIMPRO 45 mg (n=227) or gefitinib 250 mg (n=225). Randomization was stratified by region and EGFR mutation status. The primary endpoint of the study was progression-free survival (PFS) as determined by blinded Independent Radiology Central (IRC) review. Key secondary endpoints included PFS assessed by the investigator, objective response rate (ORR), duration of response (DoR), overall survival (OS), and patient-reported outcomes (PROs).
About Pfizer in Lung Cancer
Pfizer Oncology is committed to addressing the unmet needs of patients with lung cancer, the leading cause of cancer-related deaths worldwide and a particularly difficult-to-treat disease. Pfizer strives to address the diverse and evolving needs of patients with non-small cell lung cancer (NSCLC) by developing efficacious and tolerable therapies, including biomarker-driven therapies and immuno-oncology (IO) agents and combinations. By combining leading scientific insights with a patient-centric approach, Pfizer is continually advancing its work to match the right patient with the right medicine at the right time. Through our growing research pipeline and collaboration efforts, we are committed to delivering renewed hope to patients living with NSCLC.
About Pfizer Oncology
At Pfizer Oncology, we are committed to advancing medicines wherever we believe we can make a meaningful difference on the lives of patients. Today, Pfizer Oncology has an industry-leading portfolio of 18 approved innovative cancer medicines and biosimilars across more than 20 indications, including breast, prostate, kidney, lung and hematology. Pfizer Oncology is striving to change the trajectory of cancer.
Pfizer Inc: 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_News, LinkedIn, YouTube, and like us on Facebook at Facebook.com/Pfizer.
| 1 VIZIMPRO® (dacomitinib). Summary of Product Characteristics.] |
| 2 Pfizer. Data on File. |
| 3 Lovly CM, Horn L. Molecular profiling of lung cancer. My Cancer Genome; 2016. https://www.mycancergenome.org/content/disease/lung-cancer/. Accessed January 2019. |
| 4 Pao W, Miller VA. Epidermal growth factor receptor mutations, small-molecule kinase inhibitors, and non-small-cell lung cancer: current knowledge and future directions. J Clin Oncol. 2005;23:2556-2568. |
SOURCE: Pfizer
Post Views: 30
