Manish A. Shah, MD

Manish A. Shah, MD, director of the Gastrointestinal Oncology Program at Weill Cornell Medicine, chief of Solid Tumor Service, and codirector of the Center for Advanced Digestive Disease at New York-Presbyterian Hospital, discusses the design and efficacy of the DESTINY-Gastric01 trial of trastuzumab deruxtecan (T-DXd; DS-8201) in patients with HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma.

Shah found this phase 2 study to be exciting to see in this setting. Patients on DESTINY-Gastric01 were randomized 2:1 to DS-8201, a novel antibody drug conjugate, versus standard chemotherapy, which was either paclitaxel or irinotecan.

There was a statistically significant overall response rate in this trial of about 50% in patients who received DS-8201, with 11 complete responses and 50 partial responses. The median overall survival (OS) was also statistically significant at 12.5 months compared with 8.4 months for DS-8201 versus chemotherapy, respectively (HR, 0.59; 95% CI, 0.39-0.88; 

 =.0097). The 12-month OS rate was 52.1% with DS-8201 and 28.9% with chemotherapy. Based on the data, there is excitement about this drug, according to Shah. A more global follow-up study is currently being conducted.

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Videos

Manish A. Shah, MD, discusses the design and efficacy of the DESTINY-Gastric01 trial of trastuzumab deruxtecan in patients with HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma.

Analyzing the DESTINY-Gastric01 Trial for Gastric or GEJ Adenocarcinoma

Manish A. Shah, MD, director of Gastrointestinal Oncology at Weill Cornell Medicine, discusses the need for targeted therapies beyond the second-line setting in esophageal cancer. While this is a deadly disease with most metastatic patients dying within a year, a recent clinical trial with pembrolizumab (Keytruda) addresses an unmet need in the population, Shah says.

There are a few targeted therapies, including active cytotoxic drugs, that have modest activity in this patient population, but more research is necessary. Pembrolizumab, a PD-1 inhibitor, was examined in patients with esophageal cancer, both squamous cell carcinoma and adenocarcinoma, who are either PD-L1-positive or -negative.

Overall, there was a 10% response rate, including a 16% response in the PD-L1-positive population and a 6% response in the PD-L1-negative population. There also seemed to be more responses in the squamous cell carcinoma group, but Shah says all of the responses were modest. Patients benefited from the immunotherapy, living an additional 8 months or longer.

Manish A. Shah, MD, director of Gastrointestinal Oncology at Weill Cornell Medicine, discusses the need for targeted therapies beyond the second-line setting in esophageal cancer. While this is a deadly disease with most metastatic patients dying within a year, a recent clinical trial with pembrolizumab addresses an unmet need in the population, Shah says.

Exploring Immunotherapy in Patients With Esophageal Cancer

Manish A. Shah, MD, director of gastrointestinal oncology, Weill Cornell Medicine and New York-Presbyterian Hospital, discusses the differences between right- and left-sided colon cancer.

The Differences Between Right- and Left-Sided Tumors in Colon Cancer

Manish A. Shah, MD,&nbsp;director of gastrointestinal oncology, Weill Cornell Medicine and New York-Presbyterian Hospital, discusses the decreasing incidence of colon cancer diagnosis in those over the age of 50.

Exploring the Decreasing Incidence of Colon Cancer in Those Over the Age of 50

Manish A. Shah, MD, director of gastrointestinal oncology, Weill Cornell Medicine and New York-Presbyterian Hospital, discusses findings of how early-onset colorectal cancer is distinct from traditional colorectal cancer.

Findings of How Early-Onset Colorectal Cancer is Distinct From Traditional Colorectal Cancer

Manish A. Shah, MD, discusses the HERACLES clinical trial, which explored treatment with trastuzumab (Herceptin) and lapatinib (Tykerb) in patients with HER2-amplified metastatic colorectal cancer.

Manish A. Shah, MD | Authors

Articles

Analyzing the DESTINY-Gastric01 Trial for Gastric or GEJ Adenocarcinoma

Exploring Immunotherapy in Patients With Esophageal Cancer

The Differences Between Right- and Left-Sided Tumors in Colon Cancer

Exploring the Decreasing Incidence of Colon Cancer in Those Over the Age of 50

Findings of How Early-Onset Colorectal Cancer is Distinct From Traditional Colorectal Cancer

Targeting HER2 in Colorectal Cancer