Clinical Scorecard: FDA approves dostarlimab for advanced rectal cancer
At a Glance
Category
Detail
Condition
Clinical topic addressed by the source article: FDA approves dostarlimab for advanced rectal cancer
Key Mechanisms
Mechanisms or clinical associations described in the source article.
Target Population
Population described in the source article.
Care Setting
Treatment of locally advanced rectal cancer; nonoperative surveillance for patients achieving clinical complete response.
Key Highlights
FDA granted accelerated approval to dostarlimab-gxly (Jemperli) for the specified adult population.
In AZUR-1, 47% of 116 evaluable patients achieved a sustained clinical complete response for 12 months.
In AZUR-1, the objective response rate was 79%; 110 of 154 treated patients (71%) received dostarlimab alone without additional cancer treatment or disease progression.
In a separate investigator-led, single-arm trial, the sustained clinical complete response rate was 93% and the objective response rate was 100%.
Both supporting studies lacked randomized comparators; longer follow-up is needed to establish response durability.
Guideline-Based Recommendations
Diagnosis
Confirm MSI-H or dMMR status using an FDA-authorized test for solid tumors.
Management
Administer dostarlimab-gxly 500 mg intravenously every 3 weeks for up to 9 cycles, until disease progression or unacceptable toxicity.
In AZUR-1, assess tumor response using endoscopy, rectal MRI, and CT imaging.
In AZUR-1, patients achieving clinical complete response entered nonoperative management with close surveillance; patients without complete response or with recurrent or progressive disease were evaluated for standard treatment.
Monitoring & Follow-up
The prescribing information advises monitoring liver enzymes, creatinine, and thyroid function during treatment.
In AZUR-1, surveillance for patients achieving clinical complete response was every 4 months for the first 2 years and every 6 months thereafter.
Risks
The prescribing information warns of potentially severe or fatal immune-mediated adverse reactions and infusion-related reactions.
Warnings also include complications following allogeneic hematopoietic stem cell transplantation and embryo-fetal toxicity.
The approved regimen is 500 mg intravenously every 3 weeks for up to 9 cycles, until progression or unacceptable toxicity. In AZUR-1, 110 of 154 treated patients (71%) received dostarlimab alone without additional cancer treatment or disease progression.
Clinical Best Practices
Use an FDA-authorized test to establish MSI-H or dMMR status.
In AZUR-1, response was assessed with endoscopy, rectal MRI, and CT imaging.
The prescribing information advises monitoring liver enzymes, creatinine, and thyroid function during treatment.
In AZUR-1, patients managed nonoperatively after clinical complete response underwent close surveillance.
