AstraZeneca is preparing to talk to the FDA about a potential new use of its immunotherapy Imfinzi after a pivotal study in early-stage stomach cancer met its main goal.

When added to a chemotherapy combination called FLOT, Imfinzi significantly reduced the risk of disease recurrence, worsening or death in patients with resectable, early-stage gastric and gastroesophageal junction cancers who got the regimen before and after surgery, the company said Friday.

ALX Oncology Holdings Inc. (ALXO, Financials) saw its stock price fall 15.8% to $1.52 as of 2:32 p.m. GMT-5 on Thursday, despite announcing positive updated results from its ASPEN-06 Phase 2 clinical trial.

The days of broad approvals for PD-1 inhibitors in stomach and esophageal cancers appear to be numbered.

A group of external advisers to the FDA voted 10-2 that the use of PD-1 inhibitors in first-line, HER2-negative gastric cancer is not favorable in patients who have PD-L1-negative tumors, as measured by a combined positive score (CPS) or tumor area positivity (TAP) score below 1. One additional expert abstained.

Hutchmed, the original developer of Takeda’s Fruzaqla, has decided not to pursue an approval for the VEGFR inhibitor in stomach cancer for now in its home country.

After an internal review and discussions with local authorities, Hutchmed has voluntarily withdrawn its application for fruquinitib in combination with chemotherapy as a second-line treatment for advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma in China, the company said Friday. Hutchmed co-markets the drug with Eli Lilly in China under the brand name Elunate, while Takeda holds ex-China rights.

The FDA is once again gathering external experts to scrutinize PD-1 inhibitors as a group. This time, the agency is considering limiting these immunotherapies’ use in stomach cancer and esophageal cancer.

The FDA will hold an Oncologic Drugs Advisory Committee (ODAC) meeting Sept. 26 to consider whether approvals for checkpoint inhibitors in advanced gastric and gastroesophageal junction (GEJ) adenocarcinoma—as well as in esophageal squamous cell carcinoma (ESCC)—should be restricted based on tumors’ PD-L1 expression, the agency said in a public filing.

Immune checkpoint inhibitors haven’t had tons of success in stomach cancer. Now, Merck has added one failure to the mix. 

Merck’s Keytruda didn’t move the needle in terms of preventing tumors from returning when used around surgery for resectable gastric and gastroesophageal junction (GEJ) adenocarcinoma, the New Jersey pharma said Tuesday.

Merck & Co.’s Keytruda has risen from the ashes with a positive stomach cancer trial readout. But there’s some reconciliation to do with a past failure that led to the withdrawal of an accelerated approval.

Deciphera Pharmaceuticals recently took a serious hit to its billion-dollar hopeful cancer drug Qinlock. As the company undertakes a round of layoffs to deal with the blow, newly unveiled data offer a glimmer of hope for additional uptake—though likely not for an official FDA approval.