ODAC Panel Approves 4 of 6 Anti–PD-1/PD-L1 Drugs in Accelerated Approval ProgramJune 16th 2021
An FDA Oncologic Drugs Advisory Committee meeting resulted in continued approval for 4 of 6 indications that were discussed, although all 6 indications did not demonstrate clinical benefit in confirmatory studies. The meeting, held April 27-29, evaluated anti–PD-1/PD-L1 drugs that received accelerated approvals through the FDA’s accelerated approval program, a nearly 30-year-old initiative to expedite the approval process.
Roundtable Discussion: Catenacci Compares Frontline Treatment for Patients With Gastric CancerMay 20th 2021
The treatment landscape for gastric cancer is evolving. The use of biomarkers and implementation of testing to improve outcome later on in the course of treatment are being more important.
FDA Approves 1L Pembrolizumab Combination in Locally Advanced Unresectable or Metastatic HER2+ Gastric/GEJ CancersMay 5th 2021
The FDA has granted accelerated approval to pembrolizumab plus trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the frontline treatment of patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction cancer.
FDA’s ODAC Votes Against Continuation of Pembrolizumab Third-Line Indication in Gastric/GEJ CancerApril 29th 2021
The FDA’s Oncologic Drugs Advisory Committee has voted 6 to 2 against the continued approval of pembrolizumab as indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 who experienced disease progression on or after 2 or more prior lines of therapy, including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, HER2-targeted therapy.
FDA Approves Nivolumab Plus Chemotherapy as 1L Therapy for Advanced or Metastatic Gastric CancerApril 16th 2021
The FDA has approved nivolumab in combination with certain chemotherapies for the initial treatment of advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.
HER2-Expressing Gastric Cancer Cells Respond to Treatment With Trastuzumab DeruxtecanApril 10th 2021
For the treatment of patients with HER2-amplified gastric cancers in addition to those with HER2 moderate-, low-, and non-expressing disease, trastuzumab deruxtecan has shown to be an effective therapeutic option.
Adjuvant S-1 Plus Docetaxel Improves Survival in Stage III Gastric CancerJanuary 19th 2021
In the phase 2 JACCRO GC-07 trial, patients with stage III gastric cancer who received the combination of S-1 and docetaxel in the adjuvant setting had a 29% reduction in the risk of relapse.
Frontline Bemarituzumab Doublet Prolongs Survival in Advanced FGFR2b+ Gastric/GEJ CancerJanuary 16th 2021
In the frontline setting of FGFR2b-positive advanced gastric or gastroesophageal junction adenocarcinoma, the combination of bemarituzumab combined with mFOLFOX6 achieved a 56% reduction in the risk of disease progression or death compared with placebo.
FDA Grants Priority Review to sBLA for Trastuzumab Deruxtecan for HER2+ Metastatic Gastric/GEJ AdenocarcinomaOctober 28th 2020
The FDA granted a Priority Review designation to the supplemental Biologics License Application for trastuzumab deruxtecan as treatment of patients with HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma.
Janjigian Reviews the Evolving Role of Anti-HER2 Agents in Advanced Gastric CancerOctober 5th 2020
In an interview with Targeted Oncology following a virtual presentation for the ISGIO 2020, Yelena Janjigian, MD, provided an overview of the role of HER2-targeted therapies in advanced gastric cancer. She also explained the importance of biomarker testing in this space.
FDA Grants Fast Track Designation to DKN-01 in Gastric/GEJ AdenocarcinomaSeptember 24th 2020
The FDA has granted a Fast Track designation to DKN-01 for the treatment of patients with gastric and gastroesophageal junction adenocarcinoma whose tumors express the protein DKK1, following disease progression on or after prior treatment with fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, human epidermal receptor growth factor/neu-targeted therapy.
Nivolumab Plus Chemotherapy Extends PFS With Durable Responses in Gastric/GEJ CancersSeptember 21st 2020
In the phase 3 ATTRACTION-4 study, nivolumab added to chemotherapy led to a statistically significant improvement in progression-free survival and induced higher overall response rates in patients with previously untreated advanced or recurrent gastric and gastroesophageal junction cancer, according to results presented during the 2020 ESMO Virtual Congress.
Nivolumab/Ipilimumab Improves Survival Outcomes in Metastatic Gastric/GEJ CancersAugust 11th 2020
Overall survival and progression-free survival were improved with nivolumab plus ipilimumab and chemotherapy compared with chemotherapy alone as frontline treatment of patients with metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma.
HER2+ Colorectal and Gastric/GEJ Cancers Demonstrate Responses to Fam-Trastuzumab Deruxtecan TherapyMay 30th 2020
Data from 2 phase 2 trials involving fam-trastuzumab deruxtecan-nxki revealed the agent’s ability to induce responses in patients with HER2-positive metastatic colorectal cancer and advanced gastric or gastroesophageal junction adenocarcinoma.
Phase I/II Study Demonstrates Good Efficacy for Gastric CancerApril 23rd 2020
Shuichi Hironaka, MD, PhD, discusses the efficacy of a phase I/II study of nivolumab, paclitaxel, and ramucirumab as second-line treatment of patients with advanced gastric cancer during the 2020 Gastrointestinal Cancers Symposium.
FDA Grants Pembrolizumab Priority Review for TMB-High TumorsApril 7th 2020
The FDA has accepted and granted a priority review to a supplemental Biologics License Application for pembrolizumab for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors with tissue tumor mutational burden-high who have progressed following prior treatment and who have no satisfactory alternative treatment options.