Andrea Cercek, MD, on Rectal Cancer: Durable Complete Responses to PD-1 Blockade Alone
2024 ASCO Annual Meeting
Andrea Cercek, MD, of Memorial Sloan Kettering Cancer Center, discusses expanded data on the durability of complete response to dostarlimab-gxly, a PD-1 single-agent therapy administered to patients with locally advanced mismatch repair–deficient rectal cancer. The drug yielded recurrence-free responses, lasting longer than a year, without the need for chemotherapy, radiation, or surgery (LBA3512).
Transcript
Disclaimer: This video transcript has not been proofread or edited and may contain errors.
We're presenting data on the durability of clinical complete responses in mismatch repair-deficient locally advanced rectal cancer to PD-1 therapy alone. We designed a phase II clinical trial of neoadjuvant PD-1 blockade with dostarlimab in mismatch repair-deficient rectal cancer, with the idea that we could use immunotherapy alone, dostarlimab alone to treat locally advanced rectal cancer, and potentially omit standard approaches to therapy, including chemotherapy, radiation, and surgery. And we initially presented the data two years ago. In June of 2022, we noted complete responses, 100% complete responses in 14 consecutive patients. So now we're presenting the expanded data. The trial has been ongoing, and we continue to see a hundred percent complete clinical responses now in 42 patients treated with dostarlimab.
None of our patients have needed chemotherapy, radiation, or surgery. The second primary endpoint of the trial was the durability of these complete responses. And we have seen now that 24 patients have had more than a year of complete clinical responses after completion of dostarlimab. Really showing that not only are we seeing 100% complete responses, but that these responses are in fact durable in patients. And in terms of quality of life, this has been incredibly impactful for patients. None have needed chemotherapy, radiation, or surgery. And we've seen very little toxicity, only grade 1 or 2 toxicity on trial to dostarlimab, so the patient's quality of life is maintained after treatment.
There is now a global study called AZUR-1 with the same exact design, looking at neoadjuvant therapy with dostarlimab in mismatch repair-deficient rectal cancer. Which is a registration study that will hopefully provide care to all patients with early-stage mismatch repair-deficient rectal cancer, and change the standard of care in this population.
The ASCO Post Staff
Lisa A. Carey, MD, of the University of North Carolina, Chapel Hill and UNC Lineberger Comprehensive Cancer Center, and Dejan Juric, MD, of the Massachusetts General Hospital Cancer Center, discuss phase III findings on first-line use of inavolisib or placebo plus palbociclib and fulvestrant in patients with PIK3CA-mutated, hormone receptor–positive, HER2-negative locally advanced or metastatic breast cancer who relapsed within 12 months of completing adjuvant endocrine therapy (Abstract 1003).
The ASCO Post Staff
Christian U. Blank, MD, PhD, of the Netherlands Cancer Institute, discusses findings of an investigator-initiated phase III trial showing that neoadjuvant ipilimumab plus nivolumab followed by response-driven adjuvant treatment improved event-free survival in patients with macroscopic, resectable stage III melanoma compared with adjuvant nivolumab (LBA2)
The ASCO Post Staff
Efrat Dotan, MD, of Fox Chase Cancer Center, discusses results from the phase II EA2186 trial, the first prospective study aiming to define the optimal treatment approach for vulnerable older adults with newly diagnosed metastatic pancreatic cancer (Abstract 4003).
The ASCO Post Staff
Denise A. Yardley, MD, of the Sarah Cannon Research Institute, discusses the NATALEE trial, which assessed ribociclib plus a nonsteroidal aromatase inhibitor (NSAI) vs an NSAI alone in patients with hormone receptor–positive/HER2-negative early breast cancer at increased risk of recurrence, including patients with node-negative disease, and showed a benefit in invasive disease–free survival (Abstract 512).
The ASCO Post Staff
Yasmin H. Karimi, MD, of the University of Michigan Comprehensive Cancer Center, discusses data reaffirming the efficacy and feasibility of using epcoritamab plus R-DHAX/C (rituximab, dexamethasone, cytarabine, and oxaliplatin or carboplatin) in autologous stem cell transplant–eligible patients with diffuse large B-cell lymphoma. Response rates were reported to be high, and most patients proceeded to transplant (Abstract 7032).