FDA Approves First Engineered T Cell Therapy for Solid Tumors, Expands GSK’s Jemperli

First Engineered T Cell Therapy for Solid Tumors:

The FDA has granted accelerated approval to afamitresgene autoleucel (afami-cel), marketed as Tecelra, for the treatment of certain adult patients with unresectable or metastatic synovial sarcoma. This marks the first FDA-approved engineered cell therapy for a solid tumor.

Approval Details:

Afami-cel is indicated for adult patients who have received prior chemotherapy, are HLA-A02:01P, -A02:02P, -A02:03P, or -A02:
06P positive, and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices.

Clinical Trial Data:

The approval is based on findings from the SPEARHEAD-1 trial, which showed an overall response rate of 43.2% and a median duration of response of six months among the 44 patients who received afami-cel.

Safety Considerations:

The prescribing information includes a boxed warning for serious or fatal cytokine release syndrome, which may be severe or life-threatening.

Expanded Approval of Jemperli:

The FDA has also expanded the approval of dostarlimab-gxly (Jemperli) in combination with carboplatin and paclitaxel, followed by single-agent dostarlimab, for the treatment of adult patients with primary advanced or recurrent endometrial cancer. This approval now includes mismatch repair–proficient/microsatellite stable (MMRp/MSS) tumors, which represent the majority of endometrial cancer cases.

Clinical Trial Data for Jemperli:

The expanded approval is supported by data from part 1 of the phase 3 RUBY trial, which demonstrated a statistically significant improvement in overall survival (OS) and progression-free survival (PFS) in the overall population of patients with endometrial cancer.

Significance of Approvals:

These approvals represent significant advancements in the treatment of solid tumors and endometrial cancer, offering new therapeutic options for patients with limited treatment choices.