On January 17, 2017 Kura Oncology, Inc. (Nasdaq:KURA), a clinical stage biopharmaceutical company, reported that the first patient has been dosed in its Phase 2 clinical trial of tipifarnib in patients with chronic myelomonocytic leukemia (CMML) (Press release, Kura Oncology, JAN 17, 2017, View Source [SID1234517423]). Schedule your 30 min Free 1stOncology Demo! "Objective responses, including complete responses, have been previously observed with tipifarnib in CMML. Our goals with this Phase 2 study are to confirm the level of activity of tipifarnib in this patient population as well as to validate biomarker hypotheses that may allow us to identify those patients most likely to experience durable responses," said Antonio Gualberto, M.D., Ph.D., Chief Medical Officer of Kura Oncology.
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"New pharmaceutical treatments are urgently needed to combat this rare disease," said Eric Padron, M.D., of the Department of Hematologic Malignancies at H. Lee Moffitt Cancer Center and Research Institute in Tampa, Florida, a clinical investigator on this study. "Given the previous results obtained with tipifarnib in this setting and the potential to identify genetic biomarkers to prospectively select patients in future studies, we are excited to evaluate tipifarnib as a potential therapeutic for CMML."
This Phase 2 clinical trial is designed to enroll approximately 20 patients with CMML and will evaluate the antitumor activity of tipifarnib in terms of overall response rate. Patients will receive tipifarnib administered orally, twice a day for 7 days in alternating weeks in 28 day cycles. Patient samples will be analyzed for the presence or absence of various biomarkers potentially relevant to the activity of tipifarnib. Additional information about this clinical trial is available at clinicaltrials.gov using the identifier: NCT02807272.
About Chronic Myelomonocytic Leukemia
CMML is a clonal disorder of bone marrow stem cells that shares characteristics of both myeloproliferative and myelodysplastic diseases. CMML is characterized by increased monocytes and blasts in the peripheral blood and bone marrow, as well as dysplasia in at least one type of blood cell. CMML is estimated to have an annual incidence of approximately 1,400 patients in the United States. These patients generally have a poor prognosis due to limited therapeutic options with only a 29% survival rate three years after diagnosis.
About Tipifarnib
Kura Oncology’s lead program, tipifarnib, is an inhibitor of farnesylation, a key cell signaling process implicated in cancer initiation and development. In extensive clinical trials, tipifarnib has shown a well-established safety profile and compelling and durable anti-cancer activity in certain patient subsets. Preclinical and clinical data suggest that, in the appropriate context, tipifarnib has the potential to provide significant benefit to cancer patients with limited treatment options. Leveraging advances in next-generation sequencing as well as emerging information about cancer genetics and tumor biology, Kura Oncology is seeking to identify patients most likely to benefit from tipifarnib.
Year: 2017
BioLineRx Announces Initiation of Immuno-Oncology Phase 2 Study to Investigate Combination of BL-8040 and KEYTRUDA® for Pancreatic Cancer
On January 17, 2017 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, reported the initiation of a second Phase 2a trial investigating BL-8040 in combination with KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 therapy, in patients with metastatic pancreatic cancer (Filing, 6-K, BioLineRx, JAN 17, 2017, View Source [SID1234517419]). The study is part of a research collaboration between MSD and MD Anderson Cancer Center. Schedule your 30 min Free 1stOncology Demo! The open-label, single center, single-arm Phase 2a study aims to evaluate the potential of BL-8040 in combination with KEYTRUDA in pancreatic cancer and focuses on the mechanism-of-action by which both drugs might synergize. In addition to assessing clinical response, the study includes multiple assessments to evaluate the biological anti-tumor effects induced by the combination.
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In August 2016, the Company announced the signing of a collaboration agreement with The University of Texas MD Anderson Cancer Center for the investigation of BL-8040 in combination with KEYTRUDA in pancreatic cancer. The investigator-sponsored study is part of a strategic, immuno-oncology, clinical research collaboration between MSD (known as Merck in the US and Canada) and MD Anderson Cancer Center aimed at evaluating Merck’s anti-PD-1 therapy, KEYTRUDA, in combination with various treatments and novel drugs.
Philip Serlin, Chief Executive Officer of BioLineRx, said, "This is the second Phase 2 immuno-oncology trial taking place to investigate the combination of BL-8040 and KEYTRUDA for the treatment of pancreatic cancer. In September 2016, we announced the initiation of the COMBAT study, our first Phase 2a study for evaluating the clinical efficacy of BL-8040 in combination with KEYTRUDA, also for the treatment of patients with pancreatic cancer. The COMBAT study, which is being conducted by BioLineRx under a collaboration agreement between BioLineRx and MSD is also currently recruiting patients. We believe that the trial announced today will support the COMBAT study and deepen our understanding of the mechanism-of-action of the combination treatment."
"We also believe that the combination of BL-8040 with KEYTRUDA has the potential to expand the benefit of immunotherapy to non-respondent patients and cancer types currently resistant to immuno-oncology treatments, such as pancreatic cancer. Furthermore, BL-8040’s inhibition of CXCR4, which may affect the immunosuppressive tumor micro-environment, is potentially synergistic with immune checkpoint inhibitors in additional oncological indications," added Mr. Serlin.
Dr. David Fogelman, from MD Anderson Cancer Center, the principal investigator of the trial, stated, "We hope that BL-8040 will prime the immune system and increase the anti-tumor activity of Keytruda. We have designed the study to look for evidence of this, both in the tumors themselves and in the patient as a whole. If this combination is successful, we will move pancreatic cancer research forward in a new direction."
BL-8040, BioLineRx’s lead oncology platform, is a CXCR4 antagonist that has been shown in several clinical trials to be a robust mobilizer of immune cells and to be effective at inducing direct tumor cell death. Additional findings in the field of immuno-oncology suggest that CXCR4 antagonists may be effective in inducing the infiltration of anti-tumor T cells into the tumor. Therefore, when combined with KEYTRUDA, which blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes, BL-8040 has the potential to enable activated T cells to better reach tumor cells in the fight against pancreatic cancer.
About Pancreatic Cancer
Pancreatic cancers of all types are the seventh most common cause of cancer deaths. According to the American Cancer Society, in 2015, nearly 50,000 were diagnosed with pancreatic cancer and an estimated 40,000 will die from the disease. The most common type of pancreatic cancer is pancreatic adenocarcinoma, which accounts for about 85 percent of cases. These adenocarcinomas start within the part of the pancreas that makes digestive enzymes. There are usually no symptoms in the early stages of the disease and symptoms that are specific enough to suggest the onset of pancreatic cancer typically do not develop until the disease has reached an advanced stage. The five-year survival rate of pancreatic adenocarcinoma is around seven percent.
About BL-8040
BL-8040 is a short peptide for the treatment of acute myeloid leukemia, solid tumors, and certain hematological indications. It functions as a high-affinity antagonist for CXCR4, a chemokine receptor that is directly involved in tumor progression, angiogenesis, metastasis and cell survival. CXCR4 is over-expressed in more than 70% of human cancers and its expression often correlates with disease severity. In a number of clinical and pre-clinical studies, BL-8040 has shown robust mobilization of cancer cells from the bone marrow, thereby sensitizing these cells to chemo- and bio-based anti-cancer therapy, as well as a direct anti-cancer effect by inducing apoptosis. In addition, BL-8040 has also demonstrated robust stem-cell mobilization, including the mobilization of colony-forming cells, and T, B and NK cells. BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140.
AstraZeneca expands 1st-line lung cancer Immuno-Oncology programme opportunities
On January 17, 2017 AstraZeneca reported an update on its Immuno-Oncology (IO) late-stage clinical development programme in 1st-line non-small cell lung cancer (NSCLC), including a refinement of the Phase III MYSTIC trial (Press release, AstraZeneca, JAN 17, 2017, View Source [SID1234517418]). Schedule your 30 min Free 1stOncology Demo! The MYSTIC trial was initially designed to assess the benefit of durvalumab monotherapy and durvalumab and tremelimumab (durva + treme) combination therapy versus standard-of-care (SoC) chemotherapy, focused on progression-free survival (PFS).
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The MYSTIC trial will now assess PFS and overall survival (OS) endpoints in patients with PDL1-expressing tumours for both durvalumab monotherapy and the combination of durva + treme, as well as in ‘all comers’ for the combination of durva + treme, versus SoC chemotherapy.
While the focus remains on exploring the benefit of durva + treme as combination therapy, the Company has updated the endpoints of the MYSTIC trial to include OS and PFS in durvalumab monotherapy. This is based on recent internal and external data, including durvalumab’s strong efficacy in monotherapy presented at recent medical meetings, as well as significant opportunities in the competitive landscape.
The estimated primary completion date has been updated to reflect both an increase in patient recruitment (as reported in February 2016 with the inclusion of OS as a co-primary endpoint) and the event-based nature of the trial. As a result, the Company anticipates MYSTIC PFS data in mid-2017 and final OS data at the latest in 2018. MYSTIC also includes several undisclosed interim analyses for OS.
Additionally, the ongoing Phase III NEPTUNE trial will be expanded with local patients to support regulatory submission of durva + treme combination therapy in China for 1st-line NSCLC patients without delaying the anticipated OS data readout in 2018 from the global cohort, which is approaching full recruitment. The Company has also initiated the new Phase III PEARL trial of durvalumab monotherapy versus SoC chemotherapy in 1st-line NSCLC patients whose tumours express PD-L1. The PEARL trial focuses on Asian countries, primarily China, due to the high prevalence of NSCLC in the region.
All amendments will be reflected in updates to clinical trials websites, including clinicaltrials.gov.
Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: "The MYSTIC trial amendments, the NEPTUNE trial expansion and initiation of the new PEARL trial are all designed to enhance our options in 1st-line NSCLC for IO-IO combination as well as for IO monotherapy. We continue to follow the science through both internal and external sources for the benefit of patients and look forward to sharing our first pivotal data in mid-2017."
About MYSTIC
The MYSTIC trial is a randomised, open-label, multi-centre, global, Phase III trial of durvalumab in combination with tremelimumab or durvalumab monotherapy versus SoC platinum-based chemotherapy in 1st-line treatment of patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type advanced or metastatic NSCLC.
About NEPTUNE
The NEPTUNE trial is randomised, open-label, multi-centre, global, Phase III trial of durvalumab in combination with tremelimumab versus SoC platinum-based chemotherapy in 1st-line treatment of patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type advanced or metastatic NSCLC.
About PEARL
The PEARL trial is a randomised, open-label, multi-centre Phase III trial of durvalumab monotherapy versus SoC chemotherapy in 1st-line treatment of patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type advanced or metastatic PDL1-expressing NSCLC. The trial was initiated to determine the efficacy and safety of durvalumab in Asian countries, some of which have the highest current NSCLC burden, with over 1.1 million new cases projected for China alone in 2030.
About Durvalumab
Durvalumab is an investigational human monoclonal antibody directed against programmed death ligand-1 (PD-L1). PD-L1 expression enables tumours to evade detection from the immune system through binding to PD-1 on cytotoxic T lymphocytes. Durvalumab blocks PD-L1 interaction with both PD-1 and CD80 on T cells, countering the tumour’s immune- evading tactics and activating the patient’s immune system to attack the cancer. Durvalumab received FDA Breakthrough Therapy Designation in patients with PD-L1 positive inoperable or metastatic UC in 2016 and Fast Track Designation in 2015 for the treatment of patients with PD-L1 positive metastatic head and neck squamous cell carcinoma. The durvalumab biological license application (BLA) in second-line urothelial carcinoma (UC) has been accepted by the FDA with a PDUFA date in the second quarter of 2017.
AstraZeneca’s Approach to Immuno-Oncology (IO)
IO is a therapeutic approach designed to stimulate the body’s immune system to destroy tumours. At AstraZeneca, and MedImmune, our biologics research and development arm, our IO portfolio is anchored by immunotherapies that have been designed to overcome anti-tumour immune suppression. We believe that IO-based therapies will offer the potential for life-changing cancer treatments for the vast majority of patients.
We are pursuing a comprehensive clinical trial programme that includes durvalumab (PD-L1) monotherapy and durvalumab in combination with tremelimumab (CTLA-4) in multiple tumour types, stages of disease, and lines of therapy, using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient. In addition, the ability to combine our IO portfolio with small targeted molecules from across our oncology pipeline, and with those of our partners, may provide new treatment options across a broad range of tumours.
Chi-Med Presents Phase I/II Clinical Data for Selective VEGFR Inhibitor Fruquintinib at the 2017 Gastrointestinal Cancers Symposium
On January 16, 2017 Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) reported that data from the ongoing Phase I/II clinical trial of fruquintinib in combination with paclitaxel (Taxol) in second-line patients with advanced gastric cancer will be presented at the 2017 Gastrointestinal Cancers Symposium sponsored by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO-GI"), being held in San Francisco, California from January 19 to 21, 2017 (Press release, Hutchison China MediTech, JAN 16, 2017, http://www.chi-med.com/chi-med-presents-phase-iii-clinical-data-for-selective-vegfr-inhibitor-fruquintinib-at-the-2017-gastrointestinal-cancers-symposium/ [SID1234517411]). Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptors ("VEGFR").
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Chi-Med completed a Phase Ib dose finding study of fruquintinib in combination with paclitaxel, which established a combination regimen that was well tolerated, and continued to enroll patients in this trial to expand the data-set. Additional details about this study may be found at clinicaltrials.gov, using identifier NCT02415023.
The most recent results of the study will be presented in detail as follows:
Presentation Title:
A Phase I/II trial of Fruquintinib in Combination with Paclitaxel for Second-line Treatment in Patients with Advanced Gastric Cancer
Authors:
Ruihua Xu, Dongsheng Zhang, Lin Shen, Jin Li, Jing Huang, Yang Zhang, Jifang Gong, Weijian Guo, Songhua Fan, Ke Li, Ye Hua and Weiguo Su
Abstract No:
128
Session:
Poster Session A: Cancers of the Esophagus and Stomach
Date & Time: Thursday, January 19, 2017, 12:30 PM-6:30 PM (PST)
Once presented, the presentation will be available at www.chi-med.com/news. Further information about ASCO (Free ASCO Whitepaper)-GI is available at gicasym.org.
ABSTRACT
A Phase I/II Trial of Fruquintinib in Combination with Paclitaxel for Second-line Treatment in Patients with Advanced Gastric Cancer
Ruihua Xu, Dongsheng Zhang, Lin Shen, Jin Li, Jing Huang, Yang Zhang, Jifang Gong, Weijian Guo, Songhua Fan, Ke Li, Ye Hua and Weiguo Su
Background
Advanced gastric cancer is a major public health problem, particularly in Asian countries. The treatment options are limited in patients who failed standard first-line chemotherapy. This Phase I/II study is aimed to evaluate the tolerability, pharmacokinetics ("PK") and preliminary efficacy of fruquintinib, a selective oral VEGFR inhibitor, combined with paclitaxel as second-line therapy in Chinese patients with advanced gastric cancer.
Patients and methods
This open arm Phase I/II trial (NCT02415023) consisted of dose finding and dose expansion stages. In the dose finding stage, three dose levels of fruquintinib (2, 3, 4mg once daily; three-weeks-on and one-week-off) were evaluated in combination with standard 80mg/m2 paclitaxel (once weekly on day 1, 8 and 15) in a 28-day cycle until the maximum tolerated dose ("MTD") or recommended phase II dose ("RP2D") was reached. Additional patients were enrolled at dose expansion phase with fruquintinib RP2D regimen to assess further the efficacy, safety and PK profile.
Results
As of September 10, 2016, a total of 32 patients were enrolled and dosed with fruquintinib in combination with weekly paclitaxel. The RP2D of fruquintinib was determined to be 4 mg daily.
Two patients at 4 mg experienced dose-limiting toxicity, both with febrile neutropenia. Grade 3 or 4 treatment emergent adverse events ("TEAE") were neutropenia (40.6%), leukopenia (28.1%), decreased hemoglobin (6.25%), hand-foot skin reaction (6.25%), neurophlegmon (6.25%), and hypertension (6.25%), with higher frequencies in the 4mg cohort as compared with lower doses.
At steady state, fruquintinib drug exposure, i.e. the area under the curve (AUCss), increased dose-proportionally and was within the same range as given as a single agent. Paclitaxel exposure at fruquintinib RP2D (4mg) however, increased by approximately 30% as compared to that of single agent.
28 of 32 patients were evaluable for tumor response, and of these, 10 patients achieved confirmed partial response (objective response rate, ("ORR") = 35.7%), 9 patients experienced stable disease for at least 8 weeks (disease control rate, ("DCR") = 67.9%). At fruquintinib RP2D, ≥16w progression free survival ("PFS") = 50% and ≥7m overall survival ("OS") = 50%.
Conclusion
Combination therapy of fruquintinib and paclitaxel appeared to be generally well-tolerated with promising tumor response in the second-line setting in advanced gastric cancer. Further evaluation of fruquintinib in a randomized control trial is warranted.
About Gastric Cancer
Every year, it is estimated that approximately one million new patients around the world are diagnosed with gastric cancer, according to Frost & Sullivan, and in 2015 China represented approximately 44% of all newly diagnosed gastric cancer cases worldwide. The very high prevalence of gastric cancer in China as compared to the rest of the world is thought to be linked in part to food preparation habits, such as the use of certain preservatives. In 2015 there were an estimated 679,100 incidence gastric cancer cases and 498,000 mortality cases in China, according to the National Central Cancer Registry of China.
Gastric cancer is the third of most lethal cancer worldwide. As it is often diagnosed at an advanced stage, prognosis is poor with a median OS of less than 12 months. Although targeted therapy is under development in China, chemotherapy remains the mainstay of treatment for gastric cancer patients and confers only a moderate survival advantage. Accordingly, we see a high medical need for new targeted treatment options.
About Fruquintinib
Fruquintinib (HMPL-013) is a highly selective small molecule drug candidate that has been shown to inhibit VEGFR 24 hours a day via an oral dose, without known off-target toxicities. It is currently under the joint development in China by Chi-Med and its partner Eli Lilly and Company. Two late-stage, pivotal Phase III registration studies are ongoing in colorectal cancer (FRESCO) and lung cancer (FALUCA) along with the currently reported gastric cancer trial.
Colorectal: The FRESCO trial is a randomized, double-blind, placebo-controlled, multicenter, Phase III pivotal trial in patients with locally advanced or metastatic colorectal cancer who have failed at least two prior systemic antineoplastic therapies, including fluoropyrimidine, oxaliplatin and irinotecan. Enrollment was completed in May 2016. 416 patients were randomized at a 2:1 ratio to receive either: 5mg of fruquintinib orally once per day, on a three-weeks-on / one-week-off cycle, plus best supportive care ("BSC"); or placebo plus BSC. The primary endpoint is OS, with secondary endpoints including PFS, ORR, DCR and duration of response. Additional details of the FRESCO study may be found at clinicaltrials.gov, using identifier NCT02314819.
Lung: The FALUCA trial is a randomized, double-blind, placebo-controlled, multi-center, Phase III registration study targeted at treating patients with advanced non-squamous NSCLC, who have failed two lines of systemic chemotherapy. Enrollment began in December 2015. Patients are randomized at a 2:1 ratio to receive either: 5mg of fruquintinib orally once per day, on a three-weeks-on / one-week-off cycle, plus BSC; or placebo plus BSC. The primary endpoint is OS, with secondary endpoints including PFS, ORR, DCR and duration of response. Chi-Med plans to enroll approximately 520 patients in about 45 centers across China. Additional details about this study may be found at clinicaltrials.gov, using identifier NCT02691299.
Cancer Research Technology and Varleigh Dx (UK) Ltd launch test to support diagnosis of pancreatic cancer
On January 16, 2017 Cancer Research Technology (CRT), Cancer Research UK’s commercial arm, and Varleigh Dx (UK) Ltd, a clinical diagnostics development company, reported they have jointly launched a new test as an aid in the diagnosis of patients with pancreatic cancer (Press release, Cancer Research Technology, 16 16, 2017, View Source [SID1234523173]).
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This test is now CE marked, conforming to the European IVD Directive, and available for diagnostic use across the UK*.
The launch coincides with research published in the British Journal of Cancer ** showing that the test, which detects a protein called MCM5 involved in cell replication, can aid in the diagnosis of pancreatic cancer, supporting traditional cytological methods. The test is performed on samples which are routinely taken as part of the current pancreatic cancer management pathway.
Standard cytology tests, which look at cells collected from the tumour are sometimes not sufficiently sensitive to provide an accurate diagnosis. Often several repeat procedures are required to obtain a definitive diagnosis. The researchers showed that using the MCM5 test alongside standard cytology testing helped support the diagnosis of patients who had received unclear results from repeat cytological tests***.
The new laboratory test uses a simple colourimetric test to measure the concentration of antibodies bound to the MCM5 protein, which is present at higher levels in cells that are dividing rapidly, such as those found in malignant tumours.
Clive Richardson, Director of Varleigh Dx said: "This test for pancreatic cancer is the first of a number of new tests for MCM5 technology that we are developing to assist in the early detection of cancer."
The rights to commercialise the MCM5 assay – also known as the ELISA test – were licensed to Varleigh Dx by CRT after the protein biomarker was first identified as a cancer biomarker by Cancer Research UK-funded researchers at the University of Cambridge.
Professor Nick Coleman, who lead on this earlier work, added: "It’s great news that our research has led to new routes to translate these biological markers into ways to improve early diagnosis, for such an aggressive cancer."
Dr Phil L’Huillier, Cancer Research Technology’s director of business development, said: "It’s always hugely satisfying to see discoveries originally made in the lab by Cancer Research UK scientists and licenced by CRT now reaching the stage where they can benefit patients and we’re delighted to have worked with Varleigh Dx to have made this possible.
"This should mean that more patients with this aggressive form of cancer can be diagnosed at the earliest possible stage, without having to undergo multiple invasive procedures."