NEW YORK, December 3, 2018 /PRNewswire/ --
Cancer has a major impact globally, as it is among the world's leading cause of morbidity, according to National Cancer Institute. The Institute forecasts that in the U.S. alone, there will be estimated 1.73 million cases and approximately 609,640 deaths resulted from cancer in 2018. Despite the projection for the year, the estimated number of survivors is also expected to increase. According to the Institute, in 2016, there were 15.5 million cancer survivors in the U.S., but the number is projected to increase to 20.3 million by 2026. The number of survivors is growing due to the new innovations and technology within the pharmaceutical and biotechnology industry. Specifically, the oncology industry deals with prevention, diagnosis and treatment of cancer. According to data compiled by GBI Research, the global oncology market revenue is forecasted to grow from USD 118.6 Billion to USD 241.0 Billion in 2023. It is also expected to grow at a CAGR of 10.66%. The market is rapidly expanding due to the increasing demand for treatment to slow down or even prevent cancer. The industry has been shifting towards developing targeted therapies such as mAbs and cell therapies to effectively treat patients. TrovaGene, Inc. (NASDAQ: TROV), Novartis AG (NYSE: NVS), AbbVie Inc. (NYSE: ABBV), Bristol-Myers Squibb Company (NYSE: BMY), Pfizer Inc. (NYSE: PFE).
The most common forms of cancer are breast, colorectal, lung, prostate and hematological. Cancer is increasingly prevalent among patients over the age of 65. In developed countries, the number of cancer cases are expected to increase due to the increasing age of patients, rising obesity and hereditary factors. The oncology market is using targeted therapies to help patients suffering from cancer help increase the likelihood of surviv. "Faced with growing clinical workloads and decreasing margins, oncologists are under a growing amount of pressure at work," said Joe DePinto, President of Cardinal Health Specialty Solutions. "But, as our research shows, many oncologists are meeting their challenges head-on by proactively investing in tools, technology and additional clinical support staff. And today they are feeling more confident in their ability to adapt to changing trends, such as value-based care."
Trovagene, Inc. (NASDAQ: TROV) just mid-day announced breaking news that it presented, "updated data from its ongoing Phase 1b/2 study evaluating Onvansertib in combination with standard-of-care chemotherapy in Acute Myeloid Leukemia (AML).
The data, featured in a poster presentation at the 60th American Society of Hematology (ASH) Annual Meeting, demonstrate that Onvansertib, in combination with LDAC or decitabine, even at the dose-escalation phase of the trial, is benefiting patients who have relapsed/refractory Acute Myeloid Leukemia (AML), and that the combination regimen is safe and well-tolerated, with no serious adverse events (SAEs) reported to-date. Onvansertib is a first-in-class, 3rd generation, highly-selective oral Polo-like Kinase 1 (PLK1) Inhibitor that is being evaluated in an ongoing Phase 1b/2 clinical trial at nine sites in the U.S. AML is a rapidly progressing bone marrow cancer with poor survival rates compared to other leukemias. The standard of care for people with AML is intensive chemotherapy; however, for many elderly patients with AML intensive treatment is not an option. Additionally, patients with relapsed or refractory AML remain among the most challenging to treat and prognosis is poor. 'AML patients with relapsed/refractory disease have very limited, if any, treatment options,' said Dr. Amer Zeidan, Lead Investigator and Assistant Professor of Medicine at Yale School of Medicine, and Hematology expert at Yale Cancer Center. 'While we are still early in the trial where patients are being treated in the dose escalation phase, we are encouraged by the safety profile of onvansertib. Importantly, there are signs of preliminary efficacy we are already seeing in the dose escalation phase of the trial of onvansertib in combination with decitabine or low dose cytarabine. One patient has achieved an ongoing partial response; showing a significant reduction in blast count and hematologic count improvement, while 9 patients so far have stable disease. AML, especially when relapsed or refractory, is a biologically aggressive cancer, so prolonged periods of stable disease are considered clinically meaningful. We anticipate as we continue in the trial and reach the recommended Phase 2 dose that we will see additional evidence of clinical efficacy.'
'A key component of our Onvansertib clinical development program is the integration of a predicative biomarker strategy to help identify patients who are more likely to respond to treatment,' said Dr. Mark Erlander, Chief Scientific Officer of Trovagene. 'Thus far we have observed a rapid and durable inhibition of the PLK1 enzyme by Onvansertib in a subset of patients, which is also associated with a higher response to treatment, as measured by decreases in circulating and bone marrow leukemic blast cells. We believe this will provide a significant advantage as we advance our clinical trial in AML, and other cancers, and will enable us to select sub-populations of patients who will benefit most from treatment with Onvansertib.'
- Polo-like Kinase 1 (PLK1):
- Serine/threonine kinase, master regulator of cell-cycle progression
- Inhibition of PLK1 causes mitotic arrest in prometaphase and subsequent cell death
- Over-expressed in numerous cancer types, including AML, and associated with poor prognosis
- A pan-PLK inhibitor, volasertib in combination with LDAC, improved survival in a randomized Phase 2 trial in AML
- A 3rd generation PLK1 inhibitor (Onvansertib), with increased specificity, potency and pharmacologic properties was needed to optimize features that hampered future development of volasertib
- Onvansertib (also known as PCM-075 and NMS-1286937):
- Orally-bioavailable, highly-selective PLK1 inhibitor
- ~24-hour half-life
- Induces G2/M arrest and apoptosis in cancer cells, including leukemic cells
- Demonstrates synergy in combination with chemotherapies and targeted therapeutics
- Safe and well tolerated (Phase 1 dose escalation trial in patients with solid tumors)
- No trial therapy-related deaths
- No Severe Adverse Events (SAEs) were considered related to study drug treatment
- AE possibly related to Onvansertib was Grade 1 nausea in 4 patients
- Of the 19 patients evaluable for safety, 12 patients had an evaluable bone marrow biopsy to assess anti-leukemic activity based on criteria from the 2017 ELN recommendations
- Of the 12 patients evaluated for preliminary anti-leukemic activity, 1 patient had a partial response (PR), 9 patients had stable disease (SD) and 2 patients had progressive disease (PD)
Conclusions and Perspective
- Two dose-levels of Onvansertib (12 mg/m2 and 18 mg/m2) were completed, with 13 patients evaluable for safety
- 6 patients have been enrolled at the 27 mg/m2 dose-level, 3 have finished cycle 1 without experiencing dose-limiting toxicities (DLTs); 3 patients are on cycle 1 of treatment
- Preliminary efficacy in the evaluable population showed over 80% patient benefit (CR + PR + SD): 1 patient with PR, 9 patients with SD
- PLK1 inhibition by treatment was observed in 5 out of 15 patients and was associated with a higher response to treatment, measured by decreases in circulating and bone marrow blasts
- Implementation of a pTCTP biomarker strategy going forward will increase the opportunity to identify patients most likely to respond to Onvansertib
- No drug-related deaths or SAEs have been reported to-date.
Details of the poster presentation are provided below:
Title: Phase 1b Safety, Preliminary Anti-Leukemic Activity and Biomarker Analyses of the Pololike Kinase 1 (PLK1) Inhibitor, Onvansertib, in Combination with Low-Dose Cytarabine (LDAC) or Decitabine in Patients with Relapsed/Refractory Acute Myeloid Leukemia
Session Name: Session 616. Acute Myeloid Leukemia: Novel Therapy, Excluding Transplantation: Poster III
Location: Hall GH (San Diego Convention Center)
Date and Time: Monday, December 3, 2018; 6:00 PM - 8:00 PM
About the Ongoing Onvansertib Phase 1b/2 Acute Myeloid Leukemia Trial The Phase 1b/2 trial (NCT03303339) is a multi-center, open-label trial to evaluate the safety and efficacy of Onvansertib in combination with standard-of-care chemotherapy in AML patients who are ineligible for intensive induction therapy or whose disease is relapsed or refractory. In Phase 1b dose-escalation segment of the trial, the primary objective is to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D), using a traditional 3+3 design. In Phase 2 the MTD or RP2D will be administered to 32 patients to evaluate preliminary antitumor activity and to continue to evaluate the safety and tolerability of Onvansertib in combination with standard-of-care chemotherapy. This trial is being led by Jorge Cortes, M.D., Deputy Department Chair, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center and Amer Zeidan, MBBS, MHS, assistant professor of Medicine at Yale School of Medicine, and Hematology expert at Yale Cancer Center. The trial is being conducted at nine sites in the U.S.
About Onvansertib - Onvansertib is a first-in-class, 3rd generation, oral and highly-selective adenosine triphosphate (ATP) competitive inhibitor of the serine/threonine polo-like-kinase 1 (PLK 1) enzyme, which is over-expressed in multiple cancers, including leukemias, lymphomas and solid tumors. Separate studies with other PLK inhibitors have shown that inhibition of polo-like-kinases can lead to tumor cell death, including a Phase 2 study in Acute Myeloid Leukemia (AML) where response rates of up to 31% were observed when combined with a standard therapy for AML (low-dose cytarabine-LDAC) versus treatment with LDAC alone with a 13.3% response rate. A Phase 1 open-label, dose escalation safety study of Onvansertib has been completed in patients with advanced metastatic solid tumor cancers and published in Investigational New Drugs. The maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) in this trial was 24 mg/m2. Trovagene has an ongoing Phase 1b/2 clinical trial with onvansertib in AML that was accepted by the National Library of Medicine (NLM) and is now publicly viewable on www.clinicaltrials.gov. The NCT number assigned by clinicaltrials.gov for this study is NCT03303339. Onvansertib has been granted Orphan Drug Designation by the FDA in the U.S. and by the EC in the European Union (EU) for the treatment of patients with AML. Onvansertib targets the PLK1 isoform, only (not PLK2 or PLK3), is orally administered, has a 24-hour drug half-life with only mild to moderate side effects reported. Trovagene believes that targeting only PLK1 and having a favorable safety and tolerability profile, along with an improved dose/scheduling regimen will significantly improve on the outcome observed in previous studies with a former panPLK inhibitor in AML. Onvansertib has demonstrated synergy in preclinical studies with numerous chemotherapies and targeted therapeutics used to treat leukemias, lymphomas and solid tumor cancers, including FLT3 and HDAC inhibitors, taxanes, and cytotoxins. Trovagene believes the combination of its targeted PLK1 inhibitor, onvansertib, with other compounds has the potential to improve clinical efficacy in Acute Myeloid Leukemia (AML), metastatic Castration-Resistant Prostate Cancer (mCRPC), Non-Hodgkin Lymphoma (NHL), Colorectal Cancer, Triple Negative Breast Cancer (TNBC), as well as other types of cancer.
About Trovagene, Inc. - Trovagene is a clinical-stage, oncology therapeutics company, taking a precision medicine approach to develop drugs that target mitosis (cell division) to treat various types of cancer, including leukemias, lymphomas and solid tumors. Trovagene has intellectual property and proprietary technology that enables the Company to analyze circulating tumor DNA (ctDNA) and clinically actionable markers to identify patients most likely to respond to specific cancer therapies. Trovagene plans to continue to vertically integrate its tumor genomics technology with the development of targeted cancer therapeutics. For more information, please visit https://www.trovagene.com."
Novartis AG (NYSE: NVS) is reimagining medicine to improve and extend people's lives. Sandoz, a Novartis division and the pioneer and global leader in biosimilars, recently announced that the European Commission (EC) granted marketing authorization for biosimilar Ziextenzo® (pegfilgrastim). Ziextenzo is indicated to reduce the duration of neutropenia and incidence of febrile neutropenia in adult patients treated with cytotoxic (anti-cancer) chemotherapy for malignancy with the exception of chronic myeloid leukemia and myelodysplastic syndromes. These indications match those of the reference medicine. "Despite advancements in cancer treatment, febrile neutropenia remains one of the most significant complications of chemotherapy and is a major cause of morbidity," said Stefan Hendriks, Global Head of Biopharmaceuticals, Sandoz. "With the approval of Ziextenzo, a long-acting version of oncology supportive medicine filgrastim, we look forward to providing a treatment option that delivers the possibility of further reducing both the personal and financial burden of cancer."
AbbVie Inc. (NYSE: ABBV) is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. AbbVie recently announced the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for Priority Review for IMBRUVICA® (ibrutinib) in combination with obinutuzumab (GAZYVA®) in previously untreated adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). If the sNDA is approved, the use of IMBRUVICA with obinutuzumab could become the first chemotherapy-free, anti-CD20 combination approved by the FDA for the first-line treatment of CLL/SLL. IMBRUVICA is currently FDA-approved to treat adults with CLL/SLL as a single-agent for all lines of therapy and in combination with bendamustine and rituximab (BR). IMBRUVICA is a once-daily, first-in-class Bruton's tyrosine kinase (BTK) inhibitor that is administered orally, and is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc. IMBRUVICA is being studied alone and in combination with other treatments in several blood and solid tumor cancers and other serious illnesses. IMBRUVICA has one of the most robust clinical oncology development programs for a single molecule in the industry, with more than 130 ongoing clinical trials. There are approximately 30 ongoing company-sponsored trials, 14 of which are in Phase 3, and more than 100 investigator-sponsored trials and external collaborations that are active around the world. To date, more than 120,000 patients around the world have been treated with IMBRUVICA in clinical practice and clinical trials.
Bristol-Myers Squibb Company (NYSE: BMY) is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. Bristol-Myers Squibb Company recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion recommending approval of the Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) combination to include first-line treatment for patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC). This recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). The results of the CheckMate -214 study were first presented at the European Society for Medical Oncology (ESMO) 2017 Congress and were published in the New England Journal of Medicine in March 2018. "There remains a high unmet medical need for patients with advanced renal cell carcinoma," said Arvin Yang, M.D., Ph.D., Development Lead, melanoma and genitourinary cancers, Bristol-Myers Squibb. "We are encouraged by today's positive opinion from the CHMP and look forward to potentially bringing the first Immuno-Oncology combination therapy to appropriate RCC patients across the EU."
Pfizer Inc. (NYSE: PFE) applies science and its global resources to bring therapies to people that extend and significantly improve their lives. Pfizer Inc. recently announced the recipients of the Advancing Science through Pfizer Investigator Research Exchange (ASPIRE) Breast Cancer Research Awards. Four grants totaling more than USD 3 Million in funding will be awarded to investigators in the United States (U.S.) to support clinical research projects involving Pfizer compounds in breast cancer. Since 2015, Pfizer has provided more than USD 16 Million in total funding for the ASPIRE Oncology Research Awards Program across breast and hematologic cancers. "The ASPIRE awards underscore Pfizer's commitment to collaborating with investigators to expand scientific knowledge and improve the treatment of breast cancer," said Lynn McRoy, M.D., breast cancer lead, U.S. Medical Affairs, Pfizer Oncology. "The recipients of the 2018 awards submitted outstanding clinical research proposals that have the potential to advance care for people living with breast cancer."
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