BRAFTOVI plus cetuximab is the first-and-only FDA-approved targeted regimen specifically for adults with previously treated metastatic CRC with a BRAFV600E mutation
NEW YORK, NY, USA I April 08, 2020 I Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved BRAFTOVI® (encorafenib) in combination with cetuximab (marketed as ERBITUX®) for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAFV600E mutation, as detected by an FDA-approved test, after prior therapy.1 The approval is based on results from the BEACON CRC trial, the only Phase 3 trial to specifically study patients with previously treated metastatic CRC with a BRAFV600E mutation.
“We are pleased by the FDA’s approval of BRAFTOVI in combination with cetuximab, as we are committed to developing targeted medicines that can help people living with certain mutation-driven cancers,” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. “We are grateful to the patients and study investigators who participated in the Phase 3 BEACON CRC trial and are proud to now be able to offer a targeted treatment option for people with BRAFV600E-mutant metastatic CRC who have received prior therapy. Looking ahead, we’re committed to continuing to investigate this treatment regimen across earlier lines of therapy.”
Based on results from the BEACON CRC trial, BRAFTOVI plus cetuximab showed a median overall survival (OS) of 8.4 months (95% CI: 7.5, 11.0) compared with 5.4 months (95% CI: 4.8, 6.6) for Control (irinotecan with cetuximab or FOLFIRI with cetuximab) ([HR 0.60, (95% CI: 0.45, 0.79), p=0.0003]). Additionally, BRAFTOVI plus cetuximab showed an improved objective response rate (ORR) of 20% (95% CI: 13%, 29%) compared with 2% (95% CI: 0%, 7%) for Control (p<0.0001) and median progression-free survival (mPFS) was 4.2 months with BRAFTOVI plus cetuximab (95% CI: 3.7, 5.4) versus 1.5 months with Control (95% CI: 1.4, 1.7) ([HR 0.40, (95% CI: 0.31, 0.52), p<0.0001]).
“BRAF mutations are estimated to occur in up to 15% of people with metastatic colorectal cancer and represent a poor prognosis for these patients,” said Scott Kopetz, M.D., Ph.D., FACP, Associate Professor of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center. “As the first-and-only targeted regimen for people with BRAFV600E-mutant metastatic CRC who have received prior therapy, BRAFTOVI in combination with cetuximab is a much-needed new treatment option for these patients.”
The most common adverse reactions (AR) (≥ 25%) seen in patients treated with BRAFTOVI in combination with cetuximab were fatigue, nausea, diarrhea, dermatitis acneiform, abdominal pain, decreased appetite, arthralgia and rash. The full prescribing information for BRAFTOVI can be found here.
The FDA granted this application Priority Review and Breakthrough Therapy designation. The FDA grants Priority Review to medicines that may offer significant advances in treatment or may provide a treatment where no adequate therapy exists.
Pfizer is committed to ensuring that patients who are prescribed BRAFTOVI have access to this important treatment option. Pfizer is here to help patients in the U.S. understand their benefits and connect them with financial assistance resources for their prescribed Pfizer Oncology medicines.
For more information about treatment of BRAFTOVI in combination with cetuximab, visit www.braftovihcp.com.
About Colorectal Cancer
Worldwide, colorectal cancer is the third most common type of cancer in men, and the second most common in women, with approximately 1.8 million new diagnoses in 2018.2,3 In the U.S. alone, an estimated 147,950 people will be diagnosed with cancer of the colon or rectum in 2020, and approximately 53,000 are estimated to die of their disease each year.4 BRAF mutations are estimated to occur in up to 15% of people with metastatic CRC and represent a poor prognosis for these patients.5,6,7,8,9,10 The BRAFV600E mutation is the most common BRAF mutation and the risk of mortality in CRC patients with the BRAFV600E mutation is more than two times higher than for those with wild-type BRAF.7,8 BRAFV600E-mutant metastatic CRC is an area of high unmet need as there are currently no approved therapies specifically indicated for people with BRAFV600E-mutant metastatic CRC.11,12,13
About BEACON CRC
BRAFTOVI in combination with cetuximab was evaluated in the randomized, active-controlled, open-label, multicenter, Phase 3 BEACON CRC trial. Eligible patients were required to have BRAFV600E mutant metastatic CRC, as detected by an FDA-approved test, with disease progression after one or two prior regimens.
Patients were randomized 1:1:1 to one of the following treatment arms:
- BRAFTOVI 300 mg orally once daily in combination with cetuximab (BRAFTOVI/cetuximab arm)
- BRAFTOVI 300 mg orally once daily in combination with cetuximab and binimetinib
- Irinotecan with cetuximab or FOLFIRI with cetuximab (control arm)
The major efficacy outcome measure was OS. Additional efficacy outcome measures included PFS, ORR, and duration of response (DoR) as assessed by blinded independent central review (BICR). OS and PFS were assessed in all randomized patients. ORR and DoR were assessed in the subset of the first 220 patients included in the randomized portion of the BRAFTOVI/cetuximab and control arm of the study. A total of 220 patients were randomized to the BRAFTOVI/cetuximab arm and 221 to the control arm.
The trial was conducted at over 200 investigational sites in North America, South America, Europe and the Asia Pacific region. The BEACON CRC trial was conducted with support from Ono Pharmaceutical Co. Ltd., Pierre Fabre and Merck KGaA, Darmstadt, Germany (support is for sites outside of North America).
About BRAFTOVI® (encorafenib) in Metastatic Colorectal Cancer
BRAFTOVI is an oral small molecule kinase inhibitor that targets BRAF V600E. Inappropriate activation of proteins in the MAPK signaling pathway (RAS-RAF-MEK-ERK) has been shown to occur in certain cancers, including colorectal cancer.
In the U.S., BRAFTOVI is indicated, in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAFV600E mutation, as detected by an FDA-approved test, after prior therapy.
Limitations of Use: BRAFTOVI is not indicated for treatment of patients with wild-type BRAF CRC.
Pfizer has exclusive rights to BRAFTOVI in the U.S. and Canada. Ono Pharmaceutical Co. Ltd. has exclusive rights to commercialize the product in Japan and South Korea, Medison has exclusive rights to commercialize the product in Israel and Pierre Fabre has exclusive rights to commercialize the product in all other countries, including Europe, Latin America and Asia (excluding Japan and South Korea).
About Pfizer Oncology
At Pfizer Oncology, we are committed to advancing medicines wherever we believe we can make a meaningful difference in the lives of patients. Today, Pfizer Oncology has an industry-leading portfolio of 22 approved innovative cancer medicines and biosimilars across more than 30 indications, including breast, prostate, kidney and lung cancers, as well as leukemia and melanoma.
Pfizer Inc.: Breakthroughs that change patients’ lives
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, including innovative medicines and vaccines. 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.
SOURCE: Pfizer
Post Views: 158
BRAFTOVI plus cetuximab is the first-and-only FDA-approved targeted regimen specifically for adults with previously treated metastatic CRC with a BRAFV600E mutation
NEW YORK, NY, USA I April 08, 2020 I Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved BRAFTOVI® (encorafenib) in combination with cetuximab (marketed as ERBITUX®) for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAFV600E mutation, as detected by an FDA-approved test, after prior therapy.1 The approval is based on results from the BEACON CRC trial, the only Phase 3 trial to specifically study patients with previously treated metastatic CRC with a BRAFV600E mutation.
“We are pleased by the FDA’s approval of BRAFTOVI in combination with cetuximab, as we are committed to developing targeted medicines that can help people living with certain mutation-driven cancers,” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. “We are grateful to the patients and study investigators who participated in the Phase 3 BEACON CRC trial and are proud to now be able to offer a targeted treatment option for people with BRAFV600E-mutant metastatic CRC who have received prior therapy. Looking ahead, we’re committed to continuing to investigate this treatment regimen across earlier lines of therapy.”
Based on results from the BEACON CRC trial, BRAFTOVI plus cetuximab showed a median overall survival (OS) of 8.4 months (95% CI: 7.5, 11.0) compared with 5.4 months (95% CI: 4.8, 6.6) for Control (irinotecan with cetuximab or FOLFIRI with cetuximab) ([HR 0.60, (95% CI: 0.45, 0.79), p=0.0003]). Additionally, BRAFTOVI plus cetuximab showed an improved objective response rate (ORR) of 20% (95% CI: 13%, 29%) compared with 2% (95% CI: 0%, 7%) for Control (p<0.0001) and median progression-free survival (mPFS) was 4.2 months with BRAFTOVI plus cetuximab (95% CI: 3.7, 5.4) versus 1.5 months with Control (95% CI: 1.4, 1.7) ([HR 0.40, (95% CI: 0.31, 0.52), p<0.0001]).
“BRAF mutations are estimated to occur in up to 15% of people with metastatic colorectal cancer and represent a poor prognosis for these patients,” said Scott Kopetz, M.D., Ph.D., FACP, Associate Professor of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center. “As the first-and-only targeted regimen for people with BRAFV600E-mutant metastatic CRC who have received prior therapy, BRAFTOVI in combination with cetuximab is a much-needed new treatment option for these patients.”
The most common adverse reactions (AR) (≥ 25%) seen in patients treated with BRAFTOVI in combination with cetuximab were fatigue, nausea, diarrhea, dermatitis acneiform, abdominal pain, decreased appetite, arthralgia and rash. The full prescribing information for BRAFTOVI can be found here.
The FDA granted this application Priority Review and Breakthrough Therapy designation. The FDA grants Priority Review to medicines that may offer significant advances in treatment or may provide a treatment where no adequate therapy exists.
Pfizer is committed to ensuring that patients who are prescribed BRAFTOVI have access to this important treatment option. Pfizer is here to help patients in the U.S. understand their benefits and connect them with financial assistance resources for their prescribed Pfizer Oncology medicines.
For more information about treatment of BRAFTOVI in combination with cetuximab, visit www.braftovihcp.com.
About Colorectal Cancer
Worldwide, colorectal cancer is the third most common type of cancer in men, and the second most common in women, with approximately 1.8 million new diagnoses in 2018.2,3 In the U.S. alone, an estimated 147,950 people will be diagnosed with cancer of the colon or rectum in 2020, and approximately 53,000 are estimated to die of their disease each year.4 BRAF mutations are estimated to occur in up to 15% of people with metastatic CRC and represent a poor prognosis for these patients.5,6,7,8,9,10 The BRAFV600E mutation is the most common BRAF mutation and the risk of mortality in CRC patients with the BRAFV600E mutation is more than two times higher than for those with wild-type BRAF.7,8 BRAFV600E-mutant metastatic CRC is an area of high unmet need as there are currently no approved therapies specifically indicated for people with BRAFV600E-mutant metastatic CRC.11,12,13
About BEACON CRC
BRAFTOVI in combination with cetuximab was evaluated in the randomized, active-controlled, open-label, multicenter, Phase 3 BEACON CRC trial. Eligible patients were required to have BRAFV600E mutant metastatic CRC, as detected by an FDA-approved test, with disease progression after one or two prior regimens.
Patients were randomized 1:1:1 to one of the following treatment arms:
- BRAFTOVI 300 mg orally once daily in combination with cetuximab (BRAFTOVI/cetuximab arm)
- BRAFTOVI 300 mg orally once daily in combination with cetuximab and binimetinib
- Irinotecan with cetuximab or FOLFIRI with cetuximab (control arm)
The major efficacy outcome measure was OS. Additional efficacy outcome measures included PFS, ORR, and duration of response (DoR) as assessed by blinded independent central review (BICR). OS and PFS were assessed in all randomized patients. ORR and DoR were assessed in the subset of the first 220 patients included in the randomized portion of the BRAFTOVI/cetuximab and control arm of the study. A total of 220 patients were randomized to the BRAFTOVI/cetuximab arm and 221 to the control arm.
The trial was conducted at over 200 investigational sites in North America, South America, Europe and the Asia Pacific region. The BEACON CRC trial was conducted with support from Ono Pharmaceutical Co. Ltd., Pierre Fabre and Merck KGaA, Darmstadt, Germany (support is for sites outside of North America).
About BRAFTOVI® (encorafenib) in Metastatic Colorectal Cancer
BRAFTOVI is an oral small molecule kinase inhibitor that targets BRAF V600E. Inappropriate activation of proteins in the MAPK signaling pathway (RAS-RAF-MEK-ERK) has been shown to occur in certain cancers, including colorectal cancer.
In the U.S., BRAFTOVI is indicated, in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAFV600E mutation, as detected by an FDA-approved test, after prior therapy.
Limitations of Use: BRAFTOVI is not indicated for treatment of patients with wild-type BRAF CRC.
Pfizer has exclusive rights to BRAFTOVI in the U.S. and Canada. Ono Pharmaceutical Co. Ltd. has exclusive rights to commercialize the product in Japan and South Korea, Medison has exclusive rights to commercialize the product in Israel and Pierre Fabre has exclusive rights to commercialize the product in all other countries, including Europe, Latin America and Asia (excluding Japan and South Korea).
About Pfizer Oncology
At Pfizer Oncology, we are committed to advancing medicines wherever we believe we can make a meaningful difference in the lives of patients. Today, Pfizer Oncology has an industry-leading portfolio of 22 approved innovative cancer medicines and biosimilars across more than 30 indications, including breast, prostate, kidney and lung cancers, as well as leukemia and melanoma.
Pfizer Inc.: Breakthroughs that change patients’ lives
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, including innovative medicines and vaccines. 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.
SOURCE: Pfizer
Post Views: 158
