Skip to main content

by CancerConnect, Medically Reviewed by Dr. C.H. Weaver M.D. 01/2022

FDA Grants Fast Track Designation to CYNK-101 for HER2+ Gastric/GEJ Cancers

The FDA has granted a fast track designation to CYNK-101, a genetically modified natural killer (NK) cell therapy, in combination with standard frontline chemotherapy, trastuzumab (Herceptin), and pembrolizumab (Keytruda) for patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.1

Gastric Cancer CancerConnect

About CYNK-101

CYNK-101 is manufactured from human placental hematopoietic stem cells and is reported to have innate NK cell functions that can  support antibody-dependent cellular cytotoxicity (ADCC) when used in combination with other tumor-targeted monoclonal antibodies like Herceptin which targets HER2. A phase 1/2a study is currently being planned to test the safety and preliminary efficacy of the combination.

CYNK -101 is being combined with Keytruda and Herceptin which recently was granted granted accelerated approval as initial treatment for GEJ adenocarcinomas.2 The approval was based on the KEYNOTE-811 study, which was presented at the 2021 ASCO Annual Meeting shortly following the approval.3

Scroll to Continue

Recommended Articles

Non Small Cell Lung Cancer

Treatment of Stage I - IIIA Non-Small Cell Lung Cancer

Update on the management of early stage NSCLC: three trials confirm benefit of immunotherapy yet many patients still not receiving treatment.

Image placeholder title

COVID-19 Vaccines and Cancer - Evushield "Authorized"

Preventing COVID-19 in Cancer. Answers to frequently asked questions about vaccination and Evushield.

In the phase 3 study, the overall response rate was 74%  with the addition of Keytruda to standard therapy of chemotherapy and Herceptin compared with 52% for chemotherapy alone. The phase 1/2a study will assess the addition of CYNK-101 to the triplet combination after initial cytoreduction.

Gastrointestinal Cancer Newsletter 490 GI


  1. Celularity receives fast track designation from U.S. FDA for its NK cell therapy CYNK-101 in development for the first-line treatment of advanced HER2/neu positive gastric and gastroesophageal junction cancers. News release. Celularity. January 18, 2022. Accessed January 18, 2022.
  2. Janjigian YY, Kawazoe A, Yanez PE, et al. Pembrolizumab plus trastuzumab and chemotherapy for HER2+ metastatic gastric or gastroesophageal junction (G/GEJ) cancer: initial findings of the global phase 3 KEYNOTE-811 study. J Clin Oncol. 2021;39(suppl 15):4013. doi:10.1200/JCO.2021.39.15_suppl.4013
  3. FDA grants accelerated approval to pembrolizumab for HER2-positive gastric cancer. News release. FDA. May 5, 2021. Accessed January 18, 2022.