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PharmGPS® Analyses and Predictions Validated by
Results Presented at the 2017 Annual Meeting of the ASCO

According to the National Cancer Institute (NCI), the number of new cancer cases will rise to 22 million within the next two decades, and the American Society for Clinical Oncology (ASCO), with the motto of “ Conquering cancer through research, education, and promotion of the highest quality patient care”, is working with a “diverse network of more than 40,000 oncology professionals dedicated in providing the highest-quality resources in education, policy, clinical research for advancing the care for patients with cancer”.

The mammoth conference organized by ASCO, from the 2nd to the 6th June, 2017 in Chicago witnessed major developments with the potential to transform cancer care. Care of cancer patients is being transformed by the treatment of specific patient segments, genetic mutations and treatment regimens and so it is a challenge to keep up with the pace as well as to demarcate and categorize the evolution in cancer treatment, research and development. PharmGPS® is an analytical and predictive platform that provides the comprehensive development landscape in oncology, among other major therapeutic areas, including drugs in the clinical and pre-clinical stage of development and novel targets. The PharmGPS® team was at the ASCO conference in Chicago and noted with equal parts of a sense of wonder at the range of advances in therapeutic development in oncology, and a sense of accomplishment at the validation of many of the predictions by PharmGPS® about the progress of clinical developments in oncology.

PharmGPS® Projected Keytruda® Would Dominate in Treatment of Advanced Melanoma

Melanoma, the deadliest form of skin cancer, accounts for approximately 4% of all skin cancers. In the last 40 years, the incidence of melanoma has increased 15 times. The five-year survival rates for advanced/metastatic melanoma are estimated to be only 15% to 20%. There is a pressing need for more treatments to prolong the survival in advanced stage IV melanoma patients.

As predicted by PharmGPS® as early as in July 2016, Merck presented results in the latest ASCO meeting (June 4, 2017) from clinical trials of Keytruda® demonstrating sustained survival benefit in patients who completed 2-years of planned treatment as compared to treatment with Yervoy®, for unresectable/metastatic melanoma patients. Based on early results from the KEYNOTE trials, with nearly 3-years of follow-up, KEYNOTE-006, the phase 3 study demonstrated durable results: 50% of patients showed overall survival of 33.9 months, compared to 39% in the Yervoy® arm and 31% of patients with Keytruda® arm were disease progression-free at 33.9 months, compared to 14% receiving Yervoy®. The latest clinical trials, with longer follow-ups, also reported consistent safety data for Keytruda®. This supports the use of Keytruda® as a standard of care in patients with advanced disease regardless of prior treatments. PharmGPS® further envisages that new therapies that block PD-1 pathway would extend survival for the majority of the melanoma patients and may offer the prospects of longer survival after diagnosis of advanced stage.

Roche's Alecensa® betters Pfizer's Xalkori® in ALK-positive Lung Cancer Patients

Over the past decade, lung cancer treatment has experienced dramatic changes and is the major area of focus in cancer research. Among the heterogeneous group of advanced NSCLC patients, the prevalence of ALK-positive NSCLC ranges from 4% to 5%. PharmGPS® has consistently rated Alecensa® over Xalkori®. So, it was not a surprise to see that data presented at the 2017 ASCO showed that people treated with Alecensa® (alectinib) lived significantly longer without disease progression compared to Xalkori® (crizotinib) when given as first-line treatment for ALK positive NSCLC. The results from open-label ALEX study proved that Alecensa&® improved progression-free survival by 15 months over Xalkori® in ALK+ NSCLC. Further, Alecensa® also reduced the risk of death by 53% and demonstrated superior ability to penetrate and control tumor growth in the brain. PharmGPS® predicts that Alecensa® will be the new standard of care for first-line treatment for ALK-positive lung cancer, setting a new threshold decreasing the risk of progression, apart from providing a safer treatment.

Lynparza®: The New Promising Standard for BRCA-mutated Metastatic Triple Negative Breast Cancer

Triple-negative breast cancer (TNBC) is an aggressive subtype of breast cancer with an average mortality rate of 42.2%. Despite tremendous advances during the past three decades, there is currently no cure for patients diagnosed with metastatic breast cancer. However, for the first time in the history of treating TNBC patients, a targeted therapeutic agent - Lynparza® (olaparib) demonstrated benefit over the chemotherapy (considered the current standard of care for patients with HER2-negative BRCA-mutated metastatic breast cancer).

The data presented by AstraZeneca at the 2017 ASCO Annual Meeting showed that patients treated with Lynparza® had a 42% reduction in risk of their disease worsening or death compared to those who received chemotherapy (capecitabine, vinorelbine, eribulin) in the Phase III OlympiAD trial. PharmGPS® had already predicted Lynparza® as a front-runner based on earlier trial results, which was validated by the OlympiAD data presented at the ASCO 2017. Lynparza® is the first PARP inhibitor which has shown a significant benefit for patients outside of ovarian cancer.

PharmGPS® had forecasted Lynparza® in May 2016 to be a potential new medicine targeting DNA damage response in cancer cells. With an encouraging efficacy data, it will be the future standard of care for HER2-negative BRCA-mutated metastatic breast cancer. Moreover, the safety data from the OlympiAD trial was consistent with previous Lynparza® trials and did not identify any new safety concerns.

PharmGPS® IO Suite Predictions in Emerging Treatments Gains Validation in the NKTR-214 and Nivolumab Solid Tumor Study

PharmGPS® combines its proprietary suite of AI and Big Data based algorithms with scientific and clinical subject expertise in the immuno-oncology space in its PharmGPS® IO suite. By taking into consideration the signatures of the immuno-modulatory pathways, and by comprehensively capturing and analysing the clinical trial results, the PharmGPS® IO suite identifies the tumor white space in a comprehensive format with the potential to leverage the immune checkpoint monotherapies and accelerate the IO combinations for clinical development. In 2015, the PharmGPS® IO suite had presented analyses of CD-122 agonists in IO and based on preclinical data available had prioritized melanoma followed by renal cell carcinoma as the most relevant indications for CD-122 agonist based on biological relevance and unmet need; while PharmGPS® ranked NSCLC and TNBC as the most commercially relevant tumors for CD-122 agonists. Therefore, the encouraging results presented by Nektar® on its ongoing phase1/2 study of its CD-122 agonist, NKTR-214, in combination with Opdivo® in patients with either melanoma, NSCLC, renal, bladder or TNBC was a validation of the analyses and predictions in the PharmGPS® IO suite.

The PharmGPS® IO suite has analyses and predictions on 767 combination therapies and 531 monotherapies spanning 34 tumors and 109 molecular targets. These therapies have been analysed and ranked for their suitability in treating various patient segments, various genetic mutations, and for the synergy of these therapies in combination with other IO and targeted treatments. This data and analyses are being updated on a daily basis and the AI based system is forever fine tuning its analyses to account for the rapid pace and volume of research in this very important area. The PharmGPS® IO suite aims to become the premium source of analyses in the quest for safer and better treatments for cancer patients.

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