A free glossary of oncology-related terms and resource organizations.
Why use a resource like nm|OK?
Unlike reports that are 'dead on arrival' nm|OK is a constantly updated comprehensive report on every aspect of oncology drug development. click
Drugs profiled in nm|OK
nm|OK profiles over 4,310 drugs/in vivo imaging agents in development:
3,653 anticancer agents addressing over 100 cancer types and thousands of clinical indications. Of these, 1,695 are in active development; 821 have been or are currently being evaluated in clinical trials and 539 of these are targeted agents.
757 drugs for the management of complications of cancer and its treatment (pain, infection, mucositis, emesis, etc.)
nm|OK also profiles over 552 marketed drugs (anticancer agents=335, adjuncts=197) globally, providing trial results from monotherapy and combination therapy trials.
In vitro testing (IVT) products
nm|OK profiles over 200 companies and hundreds of products (screening tests, diagnostics, pharmacogenomics, prognostics, disease monitoring tests, theragnostics, etc.) in the in vitro testing area in oncology.
Enabling technologies/drug delivery
nm|OK describes hundreds of technology platforms used to discover, evaluate, optimize, and or deliver anticancer agents such as cytotoxics, synthetic nucleic acid sequences, small molecule drugs, monoclonal antibodies, fusion proteins, etc.
Targets in oncology
nm|OK describes over 1,000 molecular moieties that may be target candidates of anticancer strategies or used as in vitro testing markers.
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The headlines below refer to selected records among the hundreds updated in nm|OK within a 30-day period. A summary of the updated information, the complete records for each item on the list, and numerous other updated entries are available to subscribers upon logging in. Samples of records from each module are here.
Special reports are reviews of current developments of oncology and related drugs by indication, mechanism, delivery technology, etc. as well as personalized medicine, including biomarkers, diagnostics, theragnostics, prognostics, pharmacogenomics, disease monitoring tests, etc. Samples of special reports are here.
Tanibirumab TTAC0001, TTAC-0001
Imetelstat sodium GRN163L (formerly GRN719)
Neratinib HKI-272, PB272
hSAP, rhPTX-2, PRM-151
COP9 signalosome subunit 6 (COPS6)
Stromal antigen 2 (STAG2)
FDA Approves Avastin in Combination with Chemotherapy for the Treatment of Platinum-resistant Ovarian Cancer in the Third Line Setting
In November 2014, the FDA approved Avastin in combination with chemotherapy with paclitaxel, pegylated liposomal doxorubicin or topotecan, for the treatment of women with platinum-resistant, recurrent, epithelial ovarian, fallopian tube, or primary peritoneal cancer, previously treated with no more than two chemotherapy regimens. In August 2014, Avastin was approved in the EU for this indication. Approval was based on results from AURELIA, a phase III clinical trial (protocol ID: MO22224; 2009-011400-33; NCT00976911), in which participants were randomized to one of six treatment arms (paclitaxel, topotecan or pegylated liposomal doxorubicin with or without Avastin). The primary endpoint of the trial was investigator-assessed PFS. (more...)
Neratinib Reduces CNS Metastases in Patients With HEr2-positive Locally Recurrent or Metastatic Breast Cancer
In November 2014, top line results were presented from the multicenter, international (n=33), randomized, 2-arm, NEfERTT phase II clinical trial (protocol ID: 3144A2-3005; NEFERTT; NCT00915018) with PB272 (neratinib) plus paclitaxel versus trastuzumab (Herceptin) plus paclitaxel for the treatment of patients withHEr2-positive locally recurrent or metastatic breast cancer in the first line setting. The trial enrolled 479 patients. As expected, there was no statistically significant difference in PFS and ORR between the paclitaxel plus neratinib arm compared to the paclitaxel plus trastuzumab arm but there was a significant decrease in the incidence of CNS metastases in the neratinib arm compared to the trastuzumab arm. This represents the first randomized trial with a HEr2 targeted agent that statistically significantly reduced the incidence of CNS metastases, which may provide a meaningful point of differentiation for neratinib in the treatment of HEr2 positive breast cancer. While other HEr2 targeted drugs provide a clinically meaningful benefit to patients with HEr2 positive breast cancer, these drugs have had little impact on CNS metastases. There is an unmet clinical need for reducing the incidence of CNS metastases which may be filled with neratinib. (more...)
Merck KGaA Discontinues Clinical Development of Tecemotide (L-BLP25) as Monotherapy in Stage III Non-small Cell Lung Cancer
In September 2014, Merck KGaA decided to discontinue the worldwide clinical development program with MUC1 antigen-specific cancer immunotherapy tecemotide (L-BLP25) as a monotherapy in Stage III non-small cell lung cancer (nsclc). Those patients on active treatment with tecemotide can undergo an individual assessment by their treating physician and apply to be treated outside of the trials. The company will continue to supply tecemotide for ongoing investigator-sponsored trials in other indications in accordance with Merck KGaA’s agreements with the sponsors of these trials. (more...)
FDA Grants Merck Accelerated Approval for Keytruda (Pembrolizumab) for the Treatment of Patients With Inoperable or Metastatic Melanoma in the Second Line Setting
In September 2014, the FDA granted accelerated approval to Keytruda (pembrolizumab) dosed at 2 mg/kg every 3 weeks for the treatment of patients with inoperable or metastatic melanoma that progressed following administration of ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Accelerated approval was based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. Keytruda is the first anti-PD-1 (programmed death receptor-1) therapy to be granted by the FDA Breakthrough Therapy designation and approval for advanced melanoma. Merck plans to make Keytruda available within one week from the date of FDA approval.
Neratinib is Headed for Regulatory Filing in 2015
In July 2014, Puma Biotechnology reported top line results from ExteNET, a double blind, placebo-controlled, phase III clinical trial (protocol ID: 3144A2-3004; NCT00878709) with PB272 (neratinib) versus placebo that enrolled 2,821 patients in 41 countries with early stage HEr2-positive breast cancer who had undergone surgery and adjuvant treatment with trastuzumab. After completion of adjuvant treatment with trastuzumab, patients were randomized to extended adjuvant treatment with either neratinib or placebo for a period of one year. Patients were then followed for recurrent disease, ductal carcinoma in situ (DCIS), or death for a period of two years after randomization in the trial. (more...)
Speeding the Time it Takes to Evaluate Novel Anticancer Treatments: the I-SPY-2 Adaptive Clinical Trial
Clinical evaluation of novel anticancer agents/treatments routinely takes over 10 years and costs nearly $1 billion. Currently, numerous agents are in development for even longer lengths of time. This situation prompted the rethinking of how to evaluate the results of clinical trials in real time rather than wait until the trial’s conclusion. In this approach, referred to as adoptive design, the effectiveness of a treatment addressing a narrow clinical indication selected on validated science, is evaluated in a small patient population in real time using statistical techniques (Barker AD, etal, Clin Pharmacol Ther, Jul 2009;86(1):97-100) based on a Bayesian model to identify regimens with ≥85% predictive probability of success. In this manner, a decision can be quickly arrived at as to the treatment’s effectiveness. The first attempt to employ this approach is represented by the I-SPY 2 TRIAL (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis 2), a phase II clinical trial (protocol ID: 097517; NCT01042379) in women with newly diagnosed locally advanced breast cancer to test whether adding investigational drugs to standard chemotherapy is better than standard chemotherapy alone in the neoadjuvant setting (http://www.ispy2.org). In this trial, various agents are used to treat a small number of patients with several types of breast cancer in the adjuvant setting to determine which are most effective in which patient based on disease characteristics and biomarker expression. The trial’s primary endpoint is pathologic complete response (pCR). The trial employs a rigorous patient profile based on the biology of each participant’s tumor and the outcome of each participant who completes treatment is used to decide treatment for women who subsequently join the trial. Drugs that provide a benefit are then entered into late stage evaluation.
The Incredible Complexity of Drug Development and Personalized Medicine in Oncology-Triple Negative Breast Cancer (TNBC)
Triple negative breast cancer (TNBC) is only one of the hundreds of distinct types of cancer. It accounts for about 15% to 25% of all cases of breast cancer. TNBC, characterized by a lack of expression of the hormone receptors for estrogen and progesterone and HEr2, is an aggressive form of breast cancer with no effective treatment options. The severity of the disease and the commercial opportunity for an effective treatment that rivals the $1.5 billion market for Herceptin in triple positive breast cancer, has intensified research in this area. Most novel agents in TNBC are in early clinical development with no standouts having emerged to date. (more...)
Inhibition of the Vascular Endothelial Growth Factor (VEGF) Pathway for the Treatment of Cancer
The success of Avastin, an antiangiogenesis agent targeting the VEGF pathway, has prompted the development of numerous similarly acting agents. Avastin, with global revenues of $6,210.5 million in fiscal 2010, is the most commercially successful anticancer drug ever to reach the market. Future Oncology has published a review of VEGF inhibition in the treatment of cancer. (more...)
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