On April 17, 2015 Bristol-Myers Squibb reported that an open-label, randomized Phase III study evaluating Opdivo (nivolumab) versus docetaxel in previously treated patients with advanced non-squamous non-small cell lung cancer (NSCLC) was stopped early because an assessment conducted by the independent Data Monitoring Committee (DMC) concluded that the study met its endpoint, demonstrating superior overall survival in patients receiving Opdivo compared to the control arm (Press release, Bristol-Myers Squibb, APR 17, 2015, View Source [SID:1234503038]). The company looks forward to sharing these data with health authorities soon. Schedule your 30 min Free 1stOncology Demo! "The results of CheckMate -057 mark the second time Opdivo has demonstrated a survival advantage in lung cancer," said Michael Giordano, senior vice president, Head of Development, Oncology, Bristol-Myers Squibb. "Through our Opdivo clinical development program, we seek to bring the potential for long-term survival to a broad range of patients, across lines of therapy and stages of disease." Know more, wherever you are: CheckMate -057 investigators are being informed of the decision to stop the comparative portion of the trial. Bristol-Myers Squibb is working to ensure that eligible patients will be informed of the opportunity to continue or start treatment with Opdivo in an open-label extension as part of the company’s commitment to providing patient access to Opdivo, and characterizing long-term survival. The company will complete a full evaluation of the final CheckMate -057 data and work with investigators on the future presentation and publication of the results.
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About CheckMate -057
CheckMate -057 is a Phase III, open-label, randomized study of Opdivo versus docetaxel in previously treated patients with advanced or metastatic non-squamous NSCLC. The trial randomized 582 patients to receive either nivolumab 3 mg/kg intravenously every two weeks or docetaxel 75 mg/m2 intravenously every three weeks. The primary endpoint is overall survival. Secondary endpoints include objective response rate and progression free survival.
About Lung Cancer
Lung cancer is the leading cause of cancer deaths globally, resulting in more than 1.5 million deaths each year according the World Health Organization. NSCLC is one of the most common types of the disease and accounts for approximately 85 percent of cases. Survival rates vary depending on the stage and type of the cancer when it is diagnosed. Globally, the five-year survival rate for Stage I NSCLC is between 47 and 50 percent; for Stage IV NSCLC, the five-year survival rate drops to two percent.
Immuno-Oncology at Bristol-Myers Squibb
Surgery, radiation, cytotoxic or targeted therapies have represented the mainstay of cancer treatment over the last several decades, but long-term survival and a positive quality of life have remained elusive for many patients with advanced disease.
To address this unmet medical need, Bristol-Myers Squibb is leading research in an innovative field of cancer research and treatment known as immuno-oncology, which involves agents whose primary mechanism is to work directly with the body’s immune system to fight cancer. The company is exploring a variety of compounds and immunotherapeutic approaches for patients with different types of cancer, including researching the potential of combining immuno-oncology agents that target different and complementary pathways in the treatment of cancer.
Bristol-Myers Squibb is committed to advancing the science of immuno-oncology, with the goal of changing survival expectations and the way patients live with cancer.
About Opdivo
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that has received approval from the U.S. Food and Drug Administration as a monotherapy in two cancer indications. On March 5, 2015, Opdivo received FDA approval for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.
In the U.S., Opdivo is also indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. Opdivo became the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world on July 4, 2014 when Ono Pharmaceutical Co. announced that it received manufacturing and marketing approval in Japan for the treatment of patients with unresectable melanoma. Bristol-Myers Squibb has a broad, global development program to study Opdivo in multiple tumor types consisting of more than 50 trials – as monotherapy or in combination with other therapies – in which more than 7,000 patients have been enrolled worldwide.
IMPORTANT SAFETY INFORMATION
Immune-Mediated Pneumonitis
Severe pneumonitis or interstitial lung disease, including fatal cases, occurred with OPDIVO treatment. Across the clinical trial experience in 691 patients with solid tumors, fatal immune-mediated pneumonitis occurred in 0.7% (5/691) of patients receiving OPDIVO; no cases occurred in Trial 3. In Trial 3, immune-mediated pneumonitis occurred in 6% (7/117) of patients receiving OPDIVO including five Grade 3 and two Grade 2 cases. Monitor patients for signs and symptoms of pneumonitis. Administer corticosteroids for Grade 2 or greater pneumonitis. Permanently discontinue OPDIVO for Grade 3 or 4 and withhold OPDIVO until resolution for Grade 2.
Immune-Mediated Colitis
In Trial 3, diarrhea occurred in 21% (24/117) of patients receiving OPDIVO. Grade 3 immune-mediated colitis occurred in 0.9% (1/117) of patients. Monitor patients for immune-mediated colitis. Administer corticosteroids for Grade 2 (of more than 5 days duration), 3, or 4 colitis. Withhold OPDIVO for Grade 2 or 3. Permanently discontinue OPDIVO for Grade 4 colitis or recurrent colitis upon restarting OPDIVO.
Immune-Mediated Hepatitis
In Trial 3, the incidences of increased liver test values were AST (16%), alkaline phosphatase (14%), ALT (12%), and total bilirubin (2.7%). Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater transaminase elevations. Withhold OPDIVO for Grade 2 and permanently discontinue OPDIVO for Grade 3 or 4 immune-mediated hepatitis.
Immune-Mediated Nephritis and Renal Dysfunction
In Trial 3, the incidence of elevated creatinine was 22%. Immune-mediated renal dysfunction (Grade 2) occurred in 0.9% (1/117) of patients. Monitor patients for elevated serum creatinine prior to and periodically during treatment. For Grade 2 or 3 serum creatinine elevation, withhold OPDIVO and administer corticosteroids; if worsening or no improvement occurs, permanently discontinue OPDIVO. Administer corticosteroids for Grade 4 serum creatinine elevation and permanently discontinue OPDIVO.
Immune-Mediated Hypothyroidism and Hyperthyroidism
In Trial 3, hypothyroidism occurred in 4.3% (5/117) of patients receiving OPDIVO. Hyperthyroidism occurred in 1.7% (2/117) of patients including one Grade 2 case. Monitor thyroid function prior to and periodically during treatment. Administer hormone replacement therapy for hypothyroidism. Initiate medical management for control of hyperthyroidism.
Immune-Mediated Adverse Reactions
The following clinically significant immune-mediated adverse reactions occurred in <2% of OPDIVO-treated patients: adrenal insufficiency, uveitis, pancreatitis, facial and abducens nerve paresis, demyeliniation, autoimmune neuropathy, motor dysfunction and vasculitis. Across clinical trials of OPDIVO administered at doses 3 mg/kg and 10 mg/kg, additional clinically significant, immune-mediated adverse reactions were identified: hypophysitis, diabetic ketoacidosis, hypopituitarism, Guillain-Barré syndrome, and myasthenic syndrome. Based on the severity of adverse reaction, withhold OPDIVO, administer high-dose corticosteroids, and, if appropriate, initiate hormone- replacement therapy.
Embryofetal Toxicity
Based on its mechanism of action, OPDIVO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with OPDIVO and for at least 5 months after the last dose of OPDIVO.
Lactation
It is not known whether OPDIVO is present in human milk. Because many drugs, including antibodies, are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from OPDIVO, advise women to discontinue breastfeeding during treatment.
Serious Adverse Reactions
In Trial 3, serious adverse reactions occurred in 59% of patients receiving OPDIVO. The most frequent serious adverse drug reactions reported in ≥2% of patients were dyspnea, pneumonia, chronic obstructive pulmonary disease exacerbation, pneumonitis, hypercalcemia, pleural effusion, hemoptysis, and pain.
Common Adverse Reactions
The most common adverse reactions (≥20%) reported with OPDIVO in Trial 3 were fatigue (50%), dyspnea (38%), musculoskeletal pain (36%), decreased appetite (35%), cough (32%), nausea (29%), and constipation (24%).
Please see U.S. Full Prescribing Information for OPDIVO available at www.bms.com.
Author: [email protected]
Selumetinib granted Orphan Drug Designation by US FDA for treatment of uveal melanoma
On April 17, 2015 AstraZeneca reported that the US Food and Drug Administration has granted Orphan Drug Designation for the MEK inhibitor selumetinib, for the treatment of uveal melanoma (Press release, AstraZeneca, APR 17, 2015, View Source;selumetinib-granted-orphan-drug-designation-by-us-fda [SID:1234503032]). Schedule your 30 min Free 1stOncology Demo! Uveal melanoma is a rare disease in which cancer cells form in the tissues of the eye. It is the most common primary intraocular malignancy in adults and comprises 5% of all melanomas1,2.
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"Uveal melanoma is a rare and devastating disease for which there are currently no effective treatment options once it spreads beyond the tissues of the eye. Selumetinib could potentially become the first effective treatment for these patients. The Orphan Drug Designation is an important regulatory advancement as we further our development plans for selumetinib in uveal melanoma," said Antoine Yver, Head of Oncology, Global Medicines Development at AstraZeneca.
The Orphan Drug Designation programme provides orphan status to drugs and biologics, which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US3.
Selumetinib, originally licensed from Array BioPharma Inc., inhibits the MEK pathway in cancer cells to prevent the tumour from growing. Data from a phase III study evaluating selumetinib in combination with chemotherapy in patients with first-line metastatic uveal melanoma is expected to be available later this year. In addition to uveal melanoma, selumetinib is being investigated in Phase III studies in KRAS mutation positive lung cancer and thyroid cancer and in Phase II in children with neurofibromatosis Type 1.
Initial data from a combination study of selumetinib with other AstraZeneca pipeline molecules including AZD9291 (T790M-directed EGFR inhibitor) and MEDI4736 (anti-PD-L1) in non-small cell lung cancer will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting 2015.
AstraZeneca announces updated progression free survival data for investigational non-small cell lung cancer medicine AZD9291
On April 17, 2015 AstraZeneca reported latest data from the ongoing AURA Phase I/II study of AZD9291 in patients with advanced epidermal growth factor receptor mutation positive (EGFRm) non-small cell lung cancer (NSCLC), who also have the T790M resistance mutation (Press release, AstraZeneca, APR 17, 2015, View Source;astrazeneca-announces-update-azd9291 [SID:1234503031]). The data demonstrated a median progression free survival (PFS) of 13.5 months (95% confidence interval (CI) 8.3 months to not calculable (NC))1. These PFS findings relate to independently reviewed data from 63 patients with T790M tumours treated with AZD9291 at a dose of 80mg per day, and are based on only 38% of patients having tumour progression. Schedule your 30 min Free 1stOncology Demo! The updated data also show an overall response rate with AZD9291 80mg of 54% (95% CI 41% to 67%) and a median duration of response of 12.4 months (95% CI 8.3 months to NC). Know more, wherever you are: AZD9291 is a once daily, selective, irreversible EGFR tyrosine kinase inhibitor (TKI) designed to target both the activating sensitising mutation, EGFRm, and T790M, the genetic mutation responsible for EGFR TKI treatment resistance in up to approximately two-thirds of cases of EGFRm advanced NSCLC. There are currently no treatments specifically approved for patients with EGFRm T790M advanced NSCLC.
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Presenting the latest analysis at the European Lung Cancer Conference (ELCC) 2015 in Geneva, Switzerland, AURA principal investigator Dr Pasi A. Jänne MD, PhD, Director, Lowe Center for Thoracic Oncology Dana-Farber Cancer Institute and Professor of Medicine Harvard Medical School, emphasised the sustained activity of AZD9291 as indicated by the key parameters of patient response: "There are few treatment options currently available for patients with advanced EGFRm non-small cell lung cancer who experience disease progression due to a second mutation known as T790M. Management is usually limited to chemotherapy or re-challenge with EGFR tyrosine kinase inhibitors. As AURA continues to mature, and the trend in progression free survival and durable clinical response is maintained, this may support the potential for AZD9291 as a future treatment option for advanced EGFRm NSCLC."
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Antoine Yver, Head of Oncology, Global Medicines Development, AstraZeneca, said: "We are committed to developing novel medicines that address the significant unmet need in lung cancer by focusing on the genetic drivers underlying the disease. We are on track for a regulatory submission of AZD9291 in the US in the second quarter of this year. Our extensive clinical research programme is also investigating the potential of AZD9291 in earlier disease and in combination with other pipeline assets including immuno-oncology molecules. With this comprehensive approach, our goal is to develop a broad range of potential treatment options for patients with EGFR mutation positive non-small cell lung cancer."
The ongoing AURA Phase I/II study is investigating AZD9291 in patients with advanced NSCLC and disease progression following treatment with an EGFR TKI. As of 2 December 2014, 283 patients with EGFRm advanced NSCLC and acquired resistance to EGFR TKIs were enrolled – 31 patients in dose escalation and 252 patients in expansion cohorts. Of these patients, 163 had T790M tumours confirmed by central testing1. The updated results presented at ELCC build on previously reported data presented at the European Society for Medical Oncology 20142.
In patients treated with AZD9291 80mg, the most common all-cause adverse events (AEs) of any grade were rash, 38% (0% Grade ≥3) and diarrhea, 36% (1% Grade ≥3). Investigator-determined treatment-related Grade ≥3 AEs occurred in 14% of patients.
As of 19 March 2015, of more than 1000 patients across all studies dosed with AZD9291, interstitial lung disease (ILD) grouped term events were reported in approximately 2.7% of patients (27 events): 12 common terminology criteria for adverse events (CTCAE) grade 1–2; 13 grade ≥3; 2 currently ungraded. Of these, a total of 3 patients were reported to have died due to ILD (Grade 5).
AstraZeneca is currently also investigating AZD9291 as first line therapy for EGFRm NSCLC patients, and in combination with MEDI4736 (anti-PDL1 immunotherapy), selumetinib (MEK inhibitor) and AZD6094 (MET inhibitor) in NSCLC. Initial data will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting 2015.
NOTES TO EDITORS
1 Jänne PA, et al. A Phase I study of AZD9291 in patients with EGFR-TKI-resistant advanced NSCLC – updated progression-free survival and duration of response data. Presented at the European Lung Cancer Conference (ELCC) Annual Meeting, Geneva; 15-18 April 2015.
2 Yang, J, et al. Updated safety and efficacy from a Phase 1 study of AZD9291 in patients (pts) with EGFR-TKI-resistant non-small cell lung cancer (NSCLC). Presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting, Madrid; 26-30 September 2014. Abstract available at: View Source Accessed March 2015.
About AZD9291
AZD9291 is an investigational, highly selective, irreversible inhibitor of both activating sensitising EGFRm and the resistance mutation, T790M, while sparing the activity of wild type EGFR.2 AZD9291 is also designed to achieve minimal or no activity against two biological receptors, known as the insulin receptor and insulin-like growth factor receptor (IFGR), in order to avoid the potential for hyperglycaemia. Hyperglycaemia (high blood sugar) can lead to patients requiring treatment with additional medications.
Patients who have the EGFRm form of NSCLC, which occurs in 10-15 percent of NSCLC patients in Europe and 30-40 percent of NSCLC patients in Asia , are particularly sensitive to treatment with currently available EGFR TKIs, which block the cell signalling pathways that drive the growth of tumour cells. However, tumour cells almost always develop resistance to treatment, leading to disease progression. In up to approximately two-thirds of patients with EGFRm advanced NSCLC, this resistance is caused by a secondary mutation known as T790M. There are currently no treatments specifically approved specifically for EGFRm T790M advanced NSCLC.
AZD9291 has been granted Breakthrough Therapy designation, Orphan Drug and Fast Track status by the US Food and Drug Administration (FDA).
Aeterna Zentaris Files Additional Patent Application to Strengthen IP Protection of Zoptarelin Doxorubicin
On April 16, 2015 Aeterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ) (the "Company") reported that it has filed an application for a patent (European Patent Office priority application: EP15000132) on a novel method of manufacturing zoptarelin doxorubicin, its hybrid cytotoxic molecule that is the subject of a pivotal ZoptEC (Zoptarelin doxorubicin in Endometrial Cancer) Phase 3 clinical study in women with advanced, recurrent or metastatic endometrial cancer who have progressed and who have received one chemotherapeutic regimen with platinum and taxane (either as adjuvant or first-line treatment) (Press release, AEterna Zentaris, APR 16, 2015, View Source;q=653 [SID:1234506590]). The claimed manufacturing process is expected to result in a significant reduction in the cost of goods sold, providing a stronger competitive position for the Company.
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Zoptarelin doxorubicin is a complex molecule that combines a synthetic peptide carrier with doxorubicin, a well-known chemotherapy agent. The synthetic peptide carrier is a Luteinizing Hormone Releasing Hormone ("LHRH") agonist, a modified natural hormone with affinity for the LHRH receptor. The design of the compound allows for the specific binding and selective uptake of the cytotoxic conjugate by LHRH receptor-positive tumors. Potential benefits of this targeted approach include a better efficacy and a more favorable safety profile with lower incidence and severity of side effects as compared to doxorubicin alone.
Because zoptarelin doxorubicin is a complex molecule, it is expensive to synthesize. The patent application, which is entitled "Enzymatic process for the regioselective manufacturing of N-Fmoc-doxorubicin-14-O-dicarboxylic acid mono esters", may, if granted, make it difficult for generic manufacturers to produce the compound on a financially feasible basis after the Company’s composition of-matter patent on zoptarelin doxorubicin expires.
David A. Dodd, Chairman and Chief Executive Officer of the Company explained the significance of the patent application for the new synthesis process: "We believe that zoptarelin doxorubicin has the potential to become the first approved therapy in the U.S. for treating women within the targeted Phase 3 indication, as well as additional cancers that we might evaluate in the future. Our commitment is to ensure that patients and their physicians have such therapies that can potentially improve and extend the quality of lives. With the 2015 expiration date of the U.S. composition-of-matter patent on the horizon, we sought a means to maintain our advantage for this compound beyond the five-year period of exclusivity granted to new chemical entities, which we expect to apply to zoptarelin doxorubicin. The compound could be a very important oncology tool if our ZoptEC Phase 3 study achieves its endpoints. By reducing the complexity of production and cost of the compound, we will have greater flexibility in potentially ensuring that patients on a worldwide basis have access and can benefit from this therapy. We believe this patent, if granted, could provide that advantage by giving us a significant production and cost advantage in support of further development in additional indications. Finally, we are most proud that this manufacturing process was invented by our colleagues within the Company’s Frankfurt-based research and development staff."
The Company owns all rights to the new process. The Company intends to file a PCT patent application in January 2016, claiming priority of the filed EP patent application.
About Zoptarelin Doxorubicin
Zoptarelin doxorubicin represents a new targeting concept in oncology using a hybrid molecule composed of a synthetic peptide carrier and a well-known chemotherapy agent, doxorubicin. Zoptarelin doxorubicin is the first intravenous drug in advanced clinical development that directs the chemotherapy agent specifically to LHRH-receptor expressing tumors, resulting in a more targeted treatment with less damage to healthy tissue. The Company is currently conducting a ZoptEC (Zoptarelin doxorubicin in Endometrial Cancer) Phase 3 trial in women with advanced, recurrent or metastatic endometrial cancer, while zoptarelin doxorubicin is also in an investigator-initiated Phase 2 trial in prostate cancer. Aeterna Zentaris owns the worldwide rights to this compound except in China. On December 1, 2014, the Company entered into a Master Collaboration Agreement, a Technology Transfer and Technical Assistance Agreement and a License Agreement with Sinopharm A-Think Pharmaceuticals Co., Ltd for the development, manufacture and commercialization of zoptarelin doxorubicin in all human uses in the Peoples Republic of China, including Hong Kong and Macau. Sinopharm A-Think is a subsidiary of Sinopharm, the largest medical and healthcare group in China and on Fortune’s Global 500 list.
About Endometrial Cancer
Endometrial cancer is the most common gynecologic malignancy in developed countries and develops when abnormal cells amass to form a tumor in the lining of the uterus. It largely affects women over the age of 50 with a higher prevalence in Caucasians and a higher mortality rate among African Americans. According to the American Cancer Society, there will be more than 54,000 new cases of endometrial cancer in the U.S. alone in 2015, with about 20% of recurring disease.
Lilly, Bristol-Myers Squibb Restructure Erbitux® (cetuximab) Collaboration in North America
On April 16, 2015 Eli Lilly and Company and Bristol-Myers Squibb reported that the companies have agreed to transfer rights to Erbitux (cetuximab) in North America, including the U.S., Canada, and Puerto Rico, from Bristol-Myers Squibb to Lilly (Press release, Bristol-Myers Squibb, APR 16, 2015, View Source [SID:1234503026]). Rights include, but are not limited to, full commercialization and manufacturing operational responsibilities. The companies’ decision comes after a 14-year successful collaboration, which includes Lilly’s wholly-owned subsidiary ImClone LLC. Bristol-Myers Squibb and Lilly will work closely to ensure a smooth transition on this important product for patients with certain advanced colorectal and head and neck cancers. Schedule your 30 min Free 1stOncology Demo! "Fully bringing Erbitux into the Lilly Oncology portfolio accelerates Lilly’s commitment and leadership in gastrointestinal cancers to include an effective treatment for advanced colorectal cancer as well as head and neck cancer," said Sue Mahony, Ph.D., senior vice president and president of Lilly Oncology. "Our good work on Erbitux began with its development at ImClone and has continued with Bristol-Myers Squibb. We look forward to carrying on these efforts for people battling select advanced colorectal and head and neck cancers." Know more, wherever you are: "Bristol-Myers Squibb is incredibly proud to have built Erbitux into a major brand and an important therapy for so many patients with certain colorectal and head and neck cancers," said Murdo Gordon, head of worldwide markets, Bristol-Myers Squibb. "This agreement further aligns our Oncology organization with our prioritized opportunities in immuno-oncology, across both solid tumors and hematologic malignancies."
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The transition is expected to be completed in the fourth quarter of 2015. Bristol-Myers Squibb will receive tiered royalties based on net product sales in North America after the completion of the transition through September 2018.