Top News from ASCO GI 2018

Exelixis and Ipsen Announce Phase 3 Trial Results of Cabozantinib Demonstrating Significant Overall Survival Benefit in Patients with Previously Treated Advanced Hepatocellular Carcinoma

January 18, 2018

Exelixis, Inc. and Ipsen have announced detailed results of the pivotal phase 3 CELESTIAL trial in patients with previously treated advanced hepatocellular carcinoma (HCC) at the 2018 ASCO-GI Symposium. In CELESTIAL, cabozantinib provided a statistically significant and clinically meaningful improvement versus placebo in overall survival (OS), the trial’s primary endpoint, at the planned second interim analysis (pre-specified critical p-value ? 0.021) for the population of second- and third-line patients enrolled in this study. Median OS was 10.2 months with cabozantinib versus 8.0 months with placebo (HR 0.76, 95 percent CI 0.63-0.92; p=0.0049). Median progression-free survival (PFS) was more than doubled, at 5.2 months with cabozantinib and 1.9 months with placebo (HR 0.44, 95 percent CI 0.36-0.52; p<0.0001). Objective response rates per RECIST 1.1 were 4 percent with cabozantinib and 0.4 percent with placebo (p=0.0086). Disease control (partial response or stable disease) was achieved by 64 percent of the cabozantinib group compared with 33 percent of the placebo group.

Daiichi Sankyo Presents Updated Data for DS-8201 in Patients with HER2-Expressing Gastric Cancer

January 18, 2018

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) has announced that updated phase 1 safety and efficacy data for DS-8201, an investigational HER2-targeting antibody drug conjugate (ADC), in a subgroup of patients with HER2-expressing gastric cancer previously treated with trastuzumab and chemotherapy were presented during a poster session at the 2018 ASCO GI. Updated preliminary subgroup analysis results in 44 of 45 efficacy evaluable patients with HER2-expressing gastric cancer or gastroesophageal junction adenocarcinoma previously treated with trastuzumab and chemotherapy showed that DS-8201 demonstrated a confirmed overall response rate of 45.5 percent (20 of 44 patients) and a disease control rate of  81.8 percent (36 of 44 patients). Median duration of response was 7.0 months (95 percent CI: NR). The Kaplan-Meier estimate of median progression-free survival was 5.8 months (95 percent CI: 3.0, 8.3). A total of 17 out of 44 patients were continuing to receive treatment at the time of data cut-off.

Phase 1b/2 Study of Margetuximab in Combination with Pembrolizumab

January 18, 2018

MacroGenics, Inc., a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, has announced presentation of data from its clinical trial of margetuximab plus pembrolizumab for patients with advanced gastric and gastroesophageal junction (GEJ) cancers in a poster session at the 2018 ASCO GI. The poster was titled “Phase 1b/2 Study of Margetuximab Plus Pembrolizumab in Advanced HER2+ Gastroesophageal Junction or Gastric Adenocarcinoma.” 32% Overall response rate in second-line gastric cancer patients was observed.

First-Time Data for Merck’s KEYTRUDA® (pembrolizumab) in Patients with Previously Treated Advanced Hepatocellular Carcinoma (HCC)

January 19, 2018

Merck, known as MSD outside the United States and Canada, has announced findings from the registrational phase 2 KEYNOTE-224 trial investigating the use of KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, in patients with advanced hepatocellular carcinoma (HCC), the most common type of liver cancer, who were previously treated with systemic therapy (sorafenib). Results showed an overall response rate (ORR) of 16.3 percent (95% CI, 9.8-24.9) (n=17/104) with KEYTRUDA as monotherapy. Data also include six-month overall survival (OS) and progression-free survival (PFS) rates.

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

January 19, 2018

TRACON Pharmaceuticals, has announced that positive initial clinical data from its ongoing Phase 1b/2 study of TRC105 and Nexavar® (sorafenib) in patients with advanced hepatocellular carcinoma (HCC) were presented in a poster presentation at the 2018 ASCO GI.

Investigational Data Presented at ASCO GI Evaluate ABRAXANE® Regimen for Patients with Locally Advanced Pancreatic Cancer

January 19, 2018

Celgene Corporation has announced primary endpoint findings and updated results of secondary endpoints from the phase II international LAPACT trial of ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) plus gemcitabine in patients with locally advanced pancreatic cancer. An analysis of patients with newly diagnosed, locally advanced pancreatic cancer treated with up to 6 cycles of ABRAXANE + gemcitabine as an investigational induction therapy (n=106) found that patients had a median time to treatment failure (TTF) of 8.8 months (90% CI: 6.67-9.82), which exceeded the protocol-specified target of 6.6 months (primary endpoint). Secondary endpoints included evaluation of the disease control rate (DCR), overall response rate (ORR), progression free survival (PFS) and overall survival (OS) in patients treated with an ABRAXANE + gemcitabine induction therapy.

Merck KGaA Presents Data on Bifunctional Immunotherapy M7824

January 19, 2018

Merck KGaA, a leading science and technology company which operates its healthcare business in the U.S. and Canada as EMD Serono, has presented three abstracts on M7824, an investigational early phase PD-L1/TGF-? bifunctional immuno-oncology asset, at the ASCO 2018 Gastrointestinal Cancers Symposium. These data provided preliminary evidence that combining the anti-PD-L1 mechanism and TGF-? trap in one molecule may generate anti-tumor activity in some heavily pretreated patient populations who are in significant need of therapies that can extend survival.

Array BioPharma to Present Updated Phase 3 BEACON CRC Safety Lead-In Results of the Combination of Encorafenib, Binimetinib and Cetuximab in BRAF-Mutant Colorectal Cancer

January 20, 2018

Array BioPharma Inc. has announced the presentation of updated safety results and clinical activity from the safety lead-in of the Phase 3 BEACON CRC trial evaluating the triplet combination of encorafenib, a BRAF inhibitor, binimetinib, a MEK inhibitor and cetuximab, an anti-EGFR antibody, in patients with BRAF-mutant colorectal cancer (CRC).

Eisai Presents Results of Analysis of Phase III Trial Of Lenvima® (Lenvatinib) In Hepatocellular Carcinoma Based on Independent Imaging Review

January 22, 2018

Eisai Co., Ltd. has announced that the results of an analysis of a Phase III trial (REFLECT study / Study 304) of its in-house discovered and developed anticancer agent lenvatinib mesylate (product names: Lenvima® / Kisplyx®, “lenvatinib”) versus sorafenib as first-line treatment for unresectable hepatocellular carcinoma based on independent imaging review were presented during ASCO-GI 2018. The indipendent review confirmed the investigators’ findings of extensions in PFS and TTP as well as an increase in ORR compared to sorafenib.

 

Top News from ASCO GI 2018 last edit: 2018-01-22T19:31:49+00:00 da Luca

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