Takeda Pharmaceutical Company Limited (TSE: 4502 / NYSE: TAK) today announced that the US Food and Drug Administration (FDA) has approved ALUNBRIG (brigatinib) for adult patients with non-small cell metastatic lung cancer (CPNPC) positive for anaplastic lymphoma kinase (ALK +), as detected by an FDA approved test. This approval expands ALUNBRIG’s current indication to include the first-line scenario. ALUNBRIG is a next generation, potent and selective tyrosine kinase (TKI) inhibitor, designed to treat molecular changes in ALK.

“We are extremely proud of the positive results that ALUNBRIG has shown for patients with newly diagnosed CPNPC ALK +, especially those with brain metastases,” said Teresa Bitetti, president of Takeda’s Global Oncology Business Unit. “Through a robust clinical development program and ongoing investigations in the CPNPC treatment setting, Takeda is committed to finding solutions for people living with devastating forms of lung cancer and in need of new options. We believe this approval for ALUNBRIG it is a substantial step in the right direction and represents significant progress for Takeda’s broader lung cancer portfolio. ”

The approval is based on the results of the phase 3 ALTA 1L trial, which assesses the safety and efficacy of ALUNBRIG compared to crizotinib in adult patients with locally advanced or metastatic CPNPC ALK + who have not received prior treatment with an ALK inhibitor .

“The results of the ALTA 1L trial add brigatinib to the very reduced list of first-line treatment options for patients with ALK + lung cancer, which have proven to be superior to crizotinib. Compared to crizotinib, brigatinib has shown superior efficacy, especially among those with brain metastases. at baseline and with a low pill load, one pill a day, which is an important factor when we can control the disease for years, “said Ross Camidge, MD, PhD, holder of the Joyce Zeff Chair in Cancer Research at Lung at the University of Colorado Cancer Center. “These data established the potential of brigatinib in the first-line scenario and I am confident that FDA approval will open a new window of possibilities for doctors and their patients.”

After more than two years of follow-up, the results of the ALTA 1L trial showed that ALUNBRIG demonstrated superiority over crizotinib, with significant antitumor activity observed, especially in patients with basal brain metastases.

ALUNBRIG reduced the risk of disease progression or death by two compared to crizotinib (SLP risk ratio = 0.49), with a median progression-free survival (SLP) of 24 months, as assessed by an Independent Committee Central Blind Review (BIRC) versus 11 months for crizotinib.
 ALUNBRIG demonstrated a confirmed overall response rate (ORR) of 74% (95% CI: 66-81) for ALUNBRIG and 62% (95% CI: 53-70) for crizotinib, assessed by a BIRC.
 ALUNBRIG demonstrated a confirmed intracranial ORR for patients with measurable baseline brain metastases at 78% (95% CI: 52-94) for patients treated with ALUNBRIG and 26% (95% CI: 10-48) for treated patients with crizotinib.

“As with many forms of lung cancer, CPNPC ALK + is a complex and aggressive cancer that presents several treatment challenges for newly diagnosed patients, including those whose disease has spread to the brain,” said Andrea Stern Ferris, president and director. executive of the LUNGevity Foundation. “Having this option for newly diagnosed patients is encouraging news for the community with CPNPC ALK + and contributes to the remarkable progress we have witnessed in the treatment of lung cancer in the past decade.”

About the ALTA 1L assay

The ALTA-1L phase 3 test (acronym for THELK in Lung Cancer Trial of BrigTHEtinib in 1The Lof ALUNBRIG in adults in adults is a global multicenter, comparative, open, randomized and continuous trial involving 275 ALUNBRIG patients, n = 137, crizotinib, n = 138) with locally advanced or metastatic CPNPC ALK +, who have not received treatment prior with an ALK inhibitor. Patients received ALUNBRIG at a dose of 180 mg once a day, after a previous period of seven days receiving 90 mg once a day, or crizotinib at a dose of 250 mg twice a day.

The average age was 58 years in the ALUNBRIG arm and 60 years in the crizotinib arm. Twenty-nine percent of patients had baseline brain metastases in the ALUNBRIG arm, compared to 30% in the crizotinib arm. Twenty-six percent of patients received prior chemotherapy for advanced or metastatic disease in the ALUNBRIG arm, against 27% in the crizotinib arm.

Progression-free survival (SLP) assessed by the Independent Blind Central Review Committee (BIRC) was the main measure of effectiveness. Additional measures of effectiveness results included overall response rate (ORR) confirmed by RECIST v1.1 and intracranial ORR.

The warnings and precautions for ALUNBRIG are: interstitial lung disease (DPI) / pneumonitis, hypertension, bradycardia, visual disturbance, elevated creatine phosphokinase (CPK), elevated pancreatic enzyme, hyperglycemia and embryonic toxicity.

In the ALTA 1L trial, severe adverse reactions occurred in 33% of patients receiving ALUNBRIG. The most common serious adverse reactions, in addition to disease progression, were pneumonia (4.4%), DPI / pneumonitis (3.7%), pyrexia (2.9%), dyspnoea (2.2%), pulmonary embolism (2.2%) and asthenia (2.2%). Fatal adverse reactions, other than disease progression, occurred in 2.9% of patients and included pneumonia (1.5%), stroke (0.7%) and multiple organ dysfunction syndrome (0.7) %).

The most common adverse reactions in the ALTA 1L trial (≥ 10%) with ALUNBRIG were diarrhea (53%), rash (40%), cough (35%), hypertension (32%), fatigue (32%), nausea ( 30%), myalgia (28%), dyspnoea (25%), abdominal pain (24%) and headache (22%).

About ALUNBRIG® (brigatinibe)

ALUNBRIG is a potent and selective next generation tyrosine kinase (TKI) inhibitor that has been designed to target genetic changes in anaplastic lymphoma kinase (ALK).

Currently, ALUNBRIG is approved in more than 40 countries, including the USA, Canada and the European Union, for the treatment of people living with metastatic CPNPC with ALK + and who have taken the drug crizotinib, but have worsened the CPNPC or are intolerant to treatment with crizotinib. ALUNBRIG has also been approved in the EU as a monotherapy for the treatment of adult patients with advanced ALK + CPNPC, previously untreated with an ALK inhibitor.

ALUNBRIG has received the FDA’s Innovative Therapy Designation for the treatment of patients with CPNPC ALK +, whose tumors are resistant to crizotinib, and has also been designated an orphan drug by the FDA for the treatment of CPNPC ALK +, CPNPC ROS1 + and CPNPC EGFR +.

About CPNPC ALK +

Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, accounting for about 85% of the estimated 1.8 million new cases of lung cancer diagnosed each year worldwide, according to the Organization Mundial de Saúde.1,2 Genetic studies indicate that chromosomal rearrangements in anaplastic lymphoma kinase (ALK) are determining factors in a subset of patients with NSCLC.3 Approximately 3% to 5% of patients with metastatic NSCLC have a gene rearrangement ALK.4,5.6

Takeda is committed to continuing research and development at CPNPC to improve the lives of the approximately 40,000 patients diagnosed with this severe and rare form of lung cancer worldwide each year.7

IMPORTANT SAFETY INFORMATION ABOUT ALUNBRIG

WARNINGS AND PRECAUTIONS

Interstitial Pulmonary Disease (DPI) / pneumonitis: fatal and severe life-threatening adverse pulmonary reactions consistent with interstitial lung disease (DPI) / pneumonitis have occurred with ALUNBRIG. In the ALUNBRIG arm of the ALTA 1L trial (180 mg once daily), DPI / pneumonitis occurred in 5.1% of the patients who received ALUNBRIG. DPI / pneumonitis occurred within 8 days of starting ALUNBRIG in 2.9% of patients, with grade 3 to 4 reactions occurring in 2.2% of patients. In the ALTA trial, DPI / pneumonitis occurred in 3.7% of patients in the 90 mg group (90 mg once daily) and 9.1% of patients in the 90 → 180 mg group (180 mg once daily) and in the previous 7 days with 90 mg once a day). Adverse reactions consistent with DPI / pneumonitis have previously occurred within 9 days after starting ALUNBRIG (median onset was 2 days) in 6.4% of patients, with grade 3 to 4 reactions occurring in 2.7%. Monitor for new or worsening respiratory symptoms (eg, dyspnoea, coughing, etc.), particularly during the first week of starting ALUNBRIG. Stop using ALUNBRIG in any patient with new or worsening respiratory symptoms and immediately assess whether there is DPI / pneumonitis or other causes of respiratory symptoms (eg, pulmonary embolism, tumor progression and infectious pneumonia). For DPI / grade 1 or 2 pneumonitis, restart ALUNBRIG with dose reduction, after recovering the initial threshold, or permanently discontinue ALUNBRIG. Permanently stop ALUNBRIG for DPI / grade 3 or 4 pneumonitis or recurrence of grade 1 or 2 DPI / pneumonitis.

Hypertension: in the ALUNBRIG arm of the ALTA 1L trial (180 mg, once daily), hypertension was reported in 32% of patients receiving ALUNBRIG; grade 3 hypertension occurred in 13% of patients.In ALTA, hypertension was reported in 11% of patients in the 90 mg group who received ALUNBRIG and 21% of patients in the 90 → 180 mg group. Grade 3 hypertension occurred in 5.9% of patients in general. Check your blood pressure before treatment with ALUNBRIG. Monitor blood pressure after 2 weeks and at least monthly thereafter, during treatment with ALUNBRIG. Stop using ALUNBRIG if you have grade 3 hypertension, despite the ideal antihypertensive therapy. After resolving or improving grade 1 severity, restart ALUNBRIG at the same dosage. Consider permanently discontinuing treatment with ALUNBRIG for grade 4 hypertension or recurrence of grade 3 hypertension. Be careful when administering ALUNBRIG in combination with antihypertensive agents that cause bradycardia.

Bradycardia: in the ALUNBRIG arm of the ALTA 1L trial (180 mg once daily), heartbeats below 50 beats per minute (bpm) occurred in 8.1% of patients who received ALUNBRIG. Grade 3 bradycardia occurred in 1 patient (0.7%). In ALTA, heart rates below 50 beats per minute (bpm) occurred in 5.7% of patients in the 90 mg group and in 7.6% of patients in the 90 → 180 mg group. Grade 2 bradycardia occurred in 1 (0.9%) patient in the 90 mg group. Monitor your heart rate and blood pressure during treatment with ALUNBRIG. Monitor patients more often if it is not possible to avoid the concomitant use of a medication known to cause bradycardia. For symptomatic bradycardia, suspend ALUNBRIG and review the concomitant use of medications for those known to cause bradycardia. If a concomitant drug known to cause bradycardia is identified and discontinued or the dosage adjusted, restart the use of ALUNBRIG at the same dosage, after the symptomatic bradycardia has resolved; otherwise, reduce the dosage of ALUNBRIG after resolution of the symptomatic bradycardia. Stop ALUNBRIG for life threatening bradycardia, if the contribution of the concomitant use is not identified.

Visual disturbance: in the ALUNBRIG arm of the ALTA 1L trial (180 mg once daily), adverse reactions of grade 1 or 2 have been reported, leading to visual disturbances, including blurred vision, photophobia, photopsia and reduced visual acuity in 7.4% of patients that received ALUNBRIG.in ALTA, adverse reactions that caused visual disturbance, including blurred vision, diplopia and reduced visual acuity, were reported in 7.3% of patients treated with ALUNBRIG in the 90 mg group and 10% of patients in the 90 → 180 group mg. Grade 3 macular edema and cataracts occurred in one patient each in the 90 → 180 mg group. Advise patients to report any visual symptoms. Stop using ALUNBRIG and ask for an ophthalmological evaluation in patients with new or worsening visual symptoms of grade 2 or greater severity. After the recovery of visual disturbances of grade 2 or 3 up to severity of grade 1 or the initial threshold, restart ALUNBRIG with a reduced dosage. Permanently suspend treatment with ALUNBRIG in grade 4 visual disturbances.

Elevation of creatine phosphokinase (CPK): in the ALUNBRIG arm of the ALTA 1L trial (180 mg once daily), there was an increase in creatine phosphokinase (CPK) in 81% of patients who received ALUNBRIG. The incidence of grade 3 or 4 CPK elevation was 24%. Dosage reduction to increase CPK occurred in 15% of patients.in ALTA, the increase in CPK occurred in 27% of patients who received ALUNBRIG in the 90 mg group and 48% of patients in the 90 mg → 180 mg group. The incidence of elevation of CPK grade 3 or 4 was 2.8% in the 90 mg group and 12% in the 90 → 180 mg group. Dosage reduction for CPK elevation occurred in 1.8% of patients in the 90 mg group and 4.5% in the 90 → 180 mg group. Advise patients to report any unexplained pain, tenderness or muscle weakness. Monitor CPK levels during treatment with ALUNBRIG. Discontinue the use of ALUNBRIG if there is an increase in CPK grade 3 or 4 with muscle pain or weakness of grade 2 or higher. After resolving or recovering the CPK elevation to grade 1 or starting level, resume ALUNBRIG at the same dosage or at a reduced dosage.

Elevation of pancreatic enzymes: in the ALUNBRIG arm of the ALTA 1L trial (180 mg once daily), there was an increase in amylase in 52% of patients and an increase in grade 3 or 4 amylase in 6.8% of patients. Elevations of lipase occurred in 59% of patients and elevation of grade 3 or 4 lipase occurred in 17% of patients.in ALTA, amylase elevation occurred in 27% of patients in the 90 mg group and in 39% of patients in the 90 → 180 mg group. Elevations of lipase occurred in 21% of patients in the 90 mg group and in 45% of patients in the 90 → 180 mg group. Elevation of grade 3 or 4 amylase occurred in 3.7% of patients in the 90 mg group and in 2.7% of patients in the 90 → 180 mg group. Elevation of grade 3 or 4 lipase occurred in 4.6% of patients in the 90 mg group and 5.5% of patients in the 90 → 180 mg group. Monitor lipase and amylase during treatment with ALUNBRIG. Stop using ALUNBRIG if there is an increase in pancreatic enzymes to grade 3 or 4. After resolution or restoration to grade 1 or the initial threshold, restart ALUNBRIG at the same dosage or with a reduced dosage.

Hyperglycemia: in the ALUNBRIG arm of the ALTA 1L trial (180 mg once daily), 56% of patients who received ALUNBRIG had new or worsened hyperglycemia. Grade 3 hyperglycemia, based on laboratory assessment of fasting serum glucose levels, occurred in 7.5% of patients. In ALTA, 43% of patients who received ALUNBRIG experienced new or worsening hyperglycemia. Grade 3 hyperglycemia, based on laboratory evaluation of fasting serum glucose levels, occurred in 3.7% of patients. Two out of 20 (10%) patients with diabetes or glucose intolerance at baseline requested to start using insulin while receiving ALUNBRIG. Analyze fasting serum glucose before starting ALUNBRIG, and then monitor it periodically. Start or optimize anti-hyperglycemic drugs as needed. If adequate control of hyperglycemia cannot be achieved with optimal medical supervision, discontinue ALUNBRIG until adequate hyperglycemia control is achieved and consider reducing ALUNBRIG dosage or permanently discontinuing its use.

Embryofetal toxicity: based on its mechanism of action and findings in animals, ALUNBRIG can cause harm to the fetus when administered to pregnant women. There are no clinical data on the use of ALUNBRIG in pregnant women. Advise pregnant women about the potential risk to the fetus. Advise women with reproductive capacity to use effective non-hormonal contraceptives during treatment with ALUNBRIG and for at least 4 months after the final dose. Advise men with partners with reproductive capacity to use effective contraceptives during treatment and for at least 3 months after the last dose of ALUNBRIG.

ADVERSE REACTIONS

In ALTA 1L, severe adverse reactions occurred in 33% of patients who received ALUNBRIG. The most common serious adverse reactions, in addition to disease progression, were pneumonia (4.4%), DPI / pneumonitis (3.7%), pyrexia (2.9%), dyspnoea (2.2%), pulmonary embolism ( 2.2%) and asthenia (2.2%). Fatal adverse reactions, other than disease progression, occurred in 2.9% of patients and included pneumonia (1.5%), stroke (0.7%) and multiple organ dysfunction syndrome (0.7) %).

In ALTA, severe adverse reactions occurred in 38% of patients in the 90 mg group and in 40% of patients in the 90 → 180 mg group. The most common serious adverse reactions were pneumonia (5.5% of the total, 3.7% in the 90 mg group, and 7.3% in the 90 → 180 mg group) and DPI / pneumonia (4.6% of the total , 1.8% in the 90 mg group and 7.3% in the 90 → 180 mg group). Fatal adverse reactions occurred in 3.7% of patients and consisted of pneumonia (2 patients), sudden death, dyspnea, respiratory arrest, pulmonary embolism, bacterial meningitis and urinary septicemia (or sepsis) (1 patient each).

The most common adverse reactions (≥ 25%) with ALUNBRIG were diarrhea (49%), fatigue (39%), nausea (39%), rash (38%), cough (37%), myalgia (34%), headache (31%), hypertension (31%), vomiting (27%) and dyspnoea (26%).

DRUG INTERACTIONS

CYP3A inhibitors: avoid the concomitant use of ALUNBRIG with strong or moderate CYP3A inhibitors. Avoid grapefruit juice or grapefruit in fruit, as this can also increase plasma concentrations of brigatinib. If concomitant use of a strong or moderate CYP3A inhibitor is unavoidable, reduce the dose of ALUNBRIG.

CYP3A inducers: avoid the concomitant use of ALUNBRIG with strong or moderate CYP3A inducers. If the concomitant use of moderate CYP3A inducers cannot be avoided, increase the dose of ALUNBRIG.

CYP3A substrates: the joint administration of ALUNBRIG with sensitive CYP3A substrates, including hormonal contraceptives, can result in decreased concentrations and loss of effectiveness of sensitive CYP3A substrates.

USE IN SPECIFIC POPULATIONS

Pregnancy: the ALUNBRIGmay cause harm to the fetus. Advise women with reproductive capacity about the potential risk to the fetus.

Lactation: there are no data regarding the secretion of brigatinib in breast milk or its effect on lactating babies or milk production. Due to the potential adverse reactions in breastfeeding babies, advise women not to breastfeed during treatment with ALUNBRIG.

Men and women with reproductive capacity:

Pregnancy tests: check if there is a possibility of pregnancy in women with reproductive capacity, before starting treatment with ALUNBRIG.

Contraception: advise women with reproductive capacity to use effective non-hormonal contraceptives during treatment with ALUNBRIG and for at least 4 months after final dosing. Advise men, who have sex with women with reproductive capacity, to use effective contraceptives during treatment with ALUNBRIG and for at least 3 months after final dosing.

Infertility: ALUNBRIG can cause reduced fertility in men.

Pediatric use: the safety and efficacy of ALUNBRIG in pediatric patients has not been established.

Geriatric use: of the 359 patients enrolled in the ALUNBRIG arm of ALTA 1L and ALTA, 26.7% were 65 years old or more and 7.5% were 75 years old or more. No clinically relevant differences in safety or efficacy were observed between patients ≥ 65 years of age and younger patients.

Liver or kidney failure: no dosage adjustment is recommended for patients with mild or moderate hepatic or renal impairment. Reduce the dose of ALUNBRIG for patients with severe hepatic or renal impairment.

See the complete US prescription information for ALUNBRIG at www.ALUNBRIG.com

Takeda’s commitment to oncology

Takeda’s basic R&D mission is to provide new drugs to cancer patients worldwide, through our commitment to science, revolutionary innovation and a passion for improving patients’ lives. Whether through our hematology therapies, robust pipeline or medications for solid tumors, Takeda’s goal is to remain innovative and competitive in order to offer patients the treatments they need. For more information, visit www.takedaoncology.com.

About Takeda Pharmaceutical Company Limited

Takeda Pharmaceutical Company Limited (TSE: 4502 / NYSE: TAK) is a globally based, values-driven, research-and-development (R&D) biopharmaceutical company that is dedicated to providing better health and a better future promising for patients, converting science into highly innovative drugs. Takeda focuses its R&D efforts on four therapeutic areas: oncology, rare diseases, neuroscience and gastroenterology (GI). Takeda also makes R&D-oriented investments in plasma-derived therapies and vaccines. Our focus is on the development of highly innovative medicines, which contribute to making a difference in people’s lives, crossing borders with new treatment options and taking advantage of our enhanced collaborative R&D capability and mechanism to create a robust and diverse main line of modalities . Takeda employees are committed to improving patients’ quality of life and working with our healthcare partners in approximately 80 countries.

For more information, visit https://www.takeda.com.

USO-BRG-0125 05/20

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1 World Health Organization. Latest Global Cancer Data (Latest Global Cancer Data). https://www.who.int/cancer/PRGlobocanFinal.pdf. Accessed May 11, 2019.
2 American Cancer Society. What is Non-Small Cell Lung Cancer? (What is non-small cell lung cancer?) Https://www.cancer.org/cancer/non-small-cell-lung-cancer/about/what-is-non-small-cell-lung-cancer .html. Accessed May 11, 2019.
3 Kris MG, et al. JAMA, 2014; 311: 1998-2006.
4 Gainor JF, Varghese AM, Ou SH, et al. Clin Cancer Res. 2013; 19 (15): 4273-81.
5 Koivunen JP, Mermel C, Zejnullahu K, et al. Clin Cancer Res. 2008; 14 (13): 4275-83.
6 Wong DW, Leung EL, So KK, et al. Cancer. 2009; 115 (8): 1723-33.
7 Chia PL, Mitchell P, Dobrovic A, John T. Clin Epidemiol, 2014; 6: 423-432.

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Contact:

Japanese media

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