ASCO GI Conference Coverage

Rexahn Presents Updated Preliminary Data on RX-3117 in Pancreatic Cancer at the 2019 ASCO GI Symposium

(Associated Press) Jan 22, 2019 - Rexahn Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing innovative therapies to improve patient outcomes in cancers that are difficult to treat, presented updated, preliminary data from the ongoing Phase 2a clinical trial of RX-3117 in combination with ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) in first-line metastatic pancreatic cancer patients at the 2019 ASCO Gastrointestinal Cancers (ASCO GI) Symposium on January 18, 2019.

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TRACON Pharmaceuticals Announces Positive Data from Ongoing Phase 1b/2 Trial of TRC105 in Hepatocellular Carcinoma

(Morningstar) Jan 22, 2019 - TRACON Pharmaceuticals today announced that positive clinical data from its ongoing Phase 1b/2 study of TRC105 and Nexavar® (sorafenib) in patients with advanced hepatocellular carcinoma (HCC) were presented at the ASCO 2019 GI on January 18, 2019.

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2019 Symposium to Highlight Notable Research Advances in Gastrointestinal Cancers

(2019 ASCO GI) Jan 17, 2019 - Five noteworthy studies exploring new approaches in the treatment and management of liver, esophageal, colorectal, and colon cancers will be presented at the 2019 Gastrointestinal Cancers Symposium, taking place January 17-19, 2019 at the Moscone West Building in San Francisco, California. Abstract 5: Safety and efficacy of durvalumab following trimodality therapy for locally advanced esophageal and GEJ adenocarcinoma: Early efficacy results from Big Ten Cancer Research Consortium study.

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Taiho Oncology and Servier Present Data on LONSURF® (trifluridine/tipiracil) at ASCO 2019 Gastrointestinal Cancers Symposium (ASCO GI)

(Markets Insider) Jan 17, 2019 - Taiho Oncology, Inc. and Servier announced today that the safety and efficacy in patients with gastrectomy from the global Phase 3 TAGS trial evaluating LONSURF® in patients with previously treated metastatic gastric cancer (mGC) are consistent with the overall study results published in The Lancet Oncology.

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Five Prime Therapeutics Presents Data from Safety Lead-in to Phase 3 FIGHT Trial of Bemarituzumab at 2019 American Society of Clinical Oncology (ASCO) Gastrointestinal (GI) Cancers Symposium

(The Business Journals) Jan 17, 2019 - Five Prime Therapeutics, Inc. announced today that a poster entitled “Phase 1 Results from the Phase 1/3 FIGHT Study Evaluating Bemarituzumab and mFOLFOX6 in Advanced Gastric/GEJ Cancer” was presented today at the ASCO Gastrointestinal Cancer Symposium in San Francisco.

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Updated Clinical Data from Combination of Margetuximab and Pembrolizumab in Gastric Cancer Presented at 2019 ASCO Gastrointestinal Cancers Symposium

(MacroGenics) Jan 17, 2019 - 32.7% Objective response rate in HER2+ IHC 3+ second-line gastric cancer patients. Well tolerated in dose escalation and expansion cohorts.

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Kura Oncology Reports Clinical Activity of Tipifarnib in Subsets of Pancreatic Cancer Associated with High CXCL12 Expression

(Markets Insider) Jan 18, 2019 - Tipifarnib is a CXCL12 pathway inhibitor that may provide clinical benefit in subsets of patients with pancreatic cancer. Analysis of a previously conducted, randomized Phase 3 trial reveals patients with lymph node or liver metastases and those with no abdominal pain appear more likely to benefit from tipifarnib.

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Rafael Pharmaceuticals to Present Plan for Phase 3 Trial (AVENGER 500) of devimistat (CPI-613®) in Combination with Modified FOLFIRINOX as a First Line Treatment for Metastatic Pancreatic Cancer at 2019 Gastrointestinal Cancers Symposium

(Markets Insider) Jan 17, 2019 - Rafael Pharmaceuticals, Inc. today announced that the study plan for a Phase 3 Trial (AVENGER 500) of devimistat in combination with modified FOLFIRINOX as a first-line treatment for patients with metastatic pancreatic cancer will be presented at ASCO GI in San Francisco, California on Friday, January 18, 2019.

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Forget To Take Your Medication? A New Digital Pill Will Alert You — And Your Doctor.

(Washington Post) Jan 17, 2019 - At the Masonic Cancer Clinic at the University of Minnesota, doctors have begun pairing a sensor with a common chemotherapy drug. The sensor transmits data from inside patients' bodies to doctors. To combat patients’ fibbing and forgetfulness, Greeno has begun deploying a new tool in recent months: a pill embedded with a tiny, ingestible sensor. The sensor transmits data from inside the patient’s body to a wearable patch placed on their abdomen, which then connects to a mobile app that patients and doctors can access.

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A ‘Digital Pill’ For Cancer Patients Is Rolled Out For The First Time, In Hopes Of Improving Outcomes

(STAT) Jan 17, 2019 - A Silicon Valley company on Thursday announced what it described as the first “digital pill” program of its kind, one in which the chemotherapy pills taken by cancer patients are packaged with a sensor that can alert a physician, pharmacist, or caregiver after it has been swallowed. Seven patients — all of whom have colorectal cancer in stage 3 or stage 4 and are being treated in Minnesota — have been provided with the treatment since September, according to Proteus Digital Health. The idea is that, by tracking when patients take their drugs, health care providers will be better able to ensure medication adherence and to provide treatment guidance, with the goal of improving health outcomes.

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Bayer to Highlight New Research at ASCO GI 2019 Cancers Symposium

(Bayer U.S.) Jan 16, 2019 - Bayer will present new data from its continued research on Stivarga® (regorafenib) in metastatic colorectal cancer (mCRC) and metastatic biliary tract cancers, and Nexavar® (sorafenib) in advanced liver cancer, at the 2019 American Society of Clinical Oncology Gastrointestinal (ASCO GI) Cancers Symposium on January 17-19 in San Francisco.

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ASLAN Pharmaceuticals to Present Positive varlitinib Data in First-Line Biliary Tract Cancer in Combination With Chemotherapy at ASCO GI

(NASDAQ) Jan 14, 2019 - ASLAN Pharmaceuticals, a clinical-stage biopharmaceutical company targeting cancers that are both highly prevalent in Asia and orphan indications in the United States and Europe, today announced positive data from an ongoing multicentre phase 1b/2 clinical trial (ASLAN001-007) of varlitinib plus gemcitabine and cisplatin (gem/cis) in first-line biliary tract cancer (BTC).

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Keytruda Cuts Risk Of Death By 31% In Esophageal Cancer Trial

(Pharmaphorum [UK]) Jan 15, 2019 - MSD’s Keytruda has cut the risk of death by 31% in patients with esophageal or esophagogastric junction carcinoma or adenocarcinoma who progressed after standard therapy. The results, from the phase 3 KEYNOTE-181 study, pave the way for yet another indication for the anti PD-1 therapy, which has seen a flurry of new approvals over the last few years. The trial also looked at whether the drug would improve overall survival in patients with squamous cell histology and in the entire intention-to-treat (ITT) study population, but did not show statistical significance here despite being directionally favourable.

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Eisai To Present Results Of Post-Hoc Analyses Of Lenvima® (Lenvatinib) Phase III REFLECT Study In Hepatocellular Carcinoma At 2019 Gastrointestinal Cancers Symposium

(Eisai) Jan 15, 2019 - Eisai Co., Ltd. announced today that presentations on a series of abstracts highlighting the latest data from post-hoc analyses of a Phase III clinical study (REFLECT/Study 304) on its in-house discovered multiple receptor tyrosine kinase inhibitor lenvatinib mesylate (product name: Lenvima®, “lenvatinib”) as first-line treatment for unresectable hepatocellular carcinoma (HCC) will be presented during the 2019 Gastrointestinal Cancers Symposium (ASCO-GI) in San Francisco from January 17 to 19.

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Array BioPharma Announces 15.3 Months Median Overall Survival from the Safety Lead-in of the Phase 3 BEACON CRC Trial of the Combination BRAFTOVI®, MEKTOVI® and ERBITUX® in BRAF-Mutant Metastatic Colorectal Cancer

(Array BioPharma) Jan 14, 2019 - Array BioPharma Inc. today announced updated safety and efficacy results, including mature overall survival (OS), from the safety lead-in of the Phase 3 BEACON CRC trial evaluating the triplet combination of BRAFTOVI® (encorafenib), a BRAF inhibitor, MEKTOVI® (binimetinib), a MEK inhibitor and ERBITUX® (cetuximab), an anti-EGFR antibody, in patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC).

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Merck’s KEYTRUDA® (pembrolizumab) Reduced Risk of Death by 31 Percent Compared to Chemotherapy in Previously Treated Patients with Advanced Esophageal or Esophagogastric Junction Carcinoma Whose Tumors Expressed PD-L1 (CPS ≥10)

(Yahoo! Finance) Jan 14, 2019 - Merck, known as MSD outside the United States and Canada, today announced the first presentation of results from KEYNOTE-181, a Phase 3 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the second-line treatment of advanced or metastatic esophageal or esophagogastric junction carcinoma. In this pivotal study, KEYTRUDA met a primary endpoint by significantly improving overall survival (OS) in patients with squamous cell carcinoma or adenocarcinoma who progressed after standard therapy and whose tumors expressed PD-L1 (Combined Positive Score [CPS] greater-than or equal to 10), with a 31 percent reduction in the risk of death compared to chemotherapy (paclitaxel, docetaxel or irinotecan) (HR=0.69 [95% CI, 0.52-0.93]; p=0.0074). This represents the first time an anti-PD-1 therapy has demonstrated a survival benefit for this patient population. The primary endpoint of OS was also evaluated in patients with squamous cell histology and in the entire intention-to-treat (ITT) study population. While directionally favorable, statistical significance for OS was not met in these two patient groups. These results, as well as other study findings, are being presented at the 2019 Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco in an oral presentation on Thursday, Jan. 17 (Abstract #2).

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