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Cemiplimab Extends DFS In High-risk Cutaneous Squamous Cell Carcinoma
January 13, 2025
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Adjuvant cemiplimab prolonged DFS compared with placebo for certain patients with cutaneous squamous cell carcinoma, according to the agent's manufacturer.
Cemiplimab (Libtayo, Regeneron Pharmaceuticals) — a fully human PD-1-blocking antibody — is approved in the United States for treatment of people with cutaneous squamous cell carcinoma that spread or cannot be cured by radiation or surgery. It also is approved for treatment of certain patients with basal cell carcinoma or non-small cell lung cancer.
Adjuvant cemiplimab prolonged DFS compared with placebo for certain patients with cutaneous squamous cell carcinoma. Image: Adobe Stock.The randomized phase 3 C-POST trial included 415 patients with high-risk cutaneous squamous cell carcinoma who had undergone surgery and postoperative radiation therapy.
Patients randomly assigned to the investigational regimen received 350 mg cemiplimab via IV every 3 weeks for four cycles followed by 700 mg cemiplimab via IV every 6 weeks for 36 weeks. The other trial participants received placebo.
DFS served as the primary endpoint. Secondary endpoints included freedom from locoregional recurrence, freedom from distant recurrence, OS, cumulative incidence of second primary cutaneous squamous cell carcinoma tumors and safety.
Researchers performed the first prespecified interim analysis after median follow-up of 24 months (range, 2-64).
Results showed cemiplimab reduced risk for recurrence or death by 68% (HR = 0.32; 95% CI, 0.2-0.51) compared with placebo.
"[Although] surgery is curative for most people living with cutaneous squamous cell carcinoma, many are burdened with a higher risk [for] recurrence that can lead to death or disfiguration," Danny Rischin, MD, MBBS, FRACP, research lead of head and neck cancer and cutaneous squamous cell carcinoma in the department of medical oncology at Peter MacCallum Cancer Centre in Melbourne, Australia, said in a Regeneron-issued press release.
"At the first prespecified interim analysis, Libtayo achieved a remarkably high bar in improving disease-free survival in high-risk cutaneous squamous cell carcinoma," Rischin added. "With no currently approved options in the adjuvant setting, these landmark results demonstrate Libtayo could represent a major advance in delaying recurrence in these vulnerable patients."
A comparable percentage of patients in the cemiplimab and placebo groups experienced adverse events (91% vs. 89%). A higher percentage of those assigned cemiplimab experienced grade 3 or higher adverse events (24% vs. 14%).
Two patients in each group experienced adverse events that led to death.
The C-POST study remains ongoing, with additional follow-up planned to evaluate OS.
Complete results from the trial will be presented at a medical meeting.
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Where Keytruda Failed, Regeneron Touts Phase III Skin Cancer Win For Libtayo
Regeneron Pharmaceuticals on Monday presented positive Phase III data for its PD-1 inhibitor Libtayo, which yielded significant survival benefits when used as an adjuvant treatment for patients with high-risk cutaneous squamous cell carcinoma.
With these findings, Libtayo has become "the first and only immunotherapy" to demonstrate "statistically significant and clinically meaningful benefit" in high-risk patients with cutaneous squamous cell carcinoma (CSCC) in the adjuvant setting, the pharma noted in its news release on Monday. Merck's blockbuster Keytruda—widely regarded as a cornerstone cancer therapy—failed in this indication in August 2024.
According to the interim readout on Monday, patients who were treated with adjuvant Libtayo saw a 68% drop in the risk of disease recurrence or death versus placebo at a median follow-up of 24 months. This effect was highly statistically significant, with a p-value less than 0.0001.
As for safety, side effects of any grade arose in 91% of the Libtayo-treated patients and 89% of placebo comparators. Dropouts were common in the Libtayo group, with 10% of patients discontinuing the study due to adverse reactions, as opposed to 1.5% in the placebo arm. Two patients in each study group developed complications leading to death.
These findings underline Libtayo's "potential to also transform the treatment of high-risk resectable cutaneous squamous cell carcinoma with adjuvant treatment," Israel Low, clinical development unit head of Oncology at Regeneron, said in a statement. The pharma plans to continue the study's follow-up—including an analysis of overall survival—building up to a regulatory submission planned for the first half of 2025.
Libtayo is a fully human monoclonal antibody designed to target PD-1, in turn blocking the cancer cells' immune evasion mechanism. The treatment has been so far approved for certain types of CSCC, basal cell carcinoma and non-small cell lung cancer.
Also on Monday, at the ongoing 2025 J.P. Morgan Healthcare Conference, Regeneron provided a preview of its product sales in 2024, with Libtayo bringing in more than $1 billion last year and emerging as a "bright spot" for the pharma's earnings, BMO Capital Markets analysts wrote in an investor note.
"While it is unclear what the exact revenue total is for the drug, we view steady increases in revenue as broadly supportive of Regeneron's decision to fully invest in the franchise," the analysts wrote.
Meanwhile, Regeneron's Eylea products—widely considered to be headline franchise—returned disappointing sales. Total Eylea sales were $1.495 billion in the final quarter of 2024, coming in 1% ahead of the $1.478 billion expectation, according to the BMO note. Meanwhile, sales of the drug's more recently approved high-dose version fell 26% short of the $411 million consensus expectation with $305 million in earnings.
The fourth-quarter miss for high-dose Eylea "may raise concerns about conversion speed," according to the BMO analysts, noting that the year ahead could pose even more challenges for Regeneron and Eylea amid incoming pressure from Genentech's Vabysmo and Amgen's biosimilar Pavblu.
Cancer Therapies Approved By The FDA In December 2024
The FDA approved several drugs in December for the treatment of diseases, including pancreatic adenocarcinoma, lung cancer, skin cancer and graft-versus-host disease.
The Food and Drug Administration in December approved several new cancer drugs, including treatments for lung, pancreatic and skin cancers.
Throughout December, the Food and Drug Administration (FDA) approved several oncology drugs for the treatment of cancers including pancreatic, lung and skin.
Here is a select list of cancer therapies approved by the FDA last month.
Bizengri for Some with NSCLC, Pancreatic AdenocarcinomaThe FDA has approved Bizengri (zenocutuzumab-zbco), the first systemic therapy for patients with advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) or pancreatic adenocarcinoma whose tumors have a NRG1 gene fusion and have progressed after prior systemic therapy. This accelerated approval applies to both NSCLC and pancreatic adenocarcinoma.
The eNRGy study evaluated Bizengri's effectiveness in 64 adults with advanced or metastatic NRG1 fusion-positive NSCLC and 30 adults with advanced or metastatic NRG1 fusion-positive pancreatic adenocarcinoma whose disease had progressed after standard treatment. In the NSCLC group, the objective response rate (ORR) was 33%, with a median duration of response (DOR) of 7.4 months. The pancreatic adenocarcinoma group had a 40% ORR, with a DOR ranging from 3.7 to 16.6 months.
Glossary:Objective response rate: the percentage of patients with a partial or complete response to treatment.
Duration of response: the time that a patient's tumor response to treatment without the cancer growing or spreading.
Progression-free survival: the length of time during and after treatment when a patient with cancer lives without the disease worsening.
Imfinzi for Limited-Stage Small Cell Lung CancerImfinzi (durvalumab) was approved for adults with limited-stage small cell lung cancer who have not experienced disease progression following concurrent platinum-based chemotherapy and radiation therapy.
The ADRIATIC trial showed that Imfinzi significantly improved both overall survival and progression-free survival (PFS) compared to placebo. Median overall survival was 55.9 months for patients receiving Imfinzi versus 33.4 months for those receiving placebo. Similarly, median PFS was 16.6 months with Imfinzi compared to 9.2 months with placebo.
Unloxcyt for Locally Advanced, Metastatic Skin Cancer SubsetThe FDA granted approval to Unloxcyt (cosibelimab-ipdl) for the treatment of patients with locally advanced or metastatic cutaneous squamous cell carcinoma (a type of skin cancer) who are not candidates for curative surgery or radiation. Unloxcyt is a PD-L1-blocking antibody, a type of immune checkpoint inhibitor that helps the body's immune system target and destroy cancer cells.
In a clinical trial, researchers assessed the ORR and DOR to the treatment. The ORR was 47% in 78 patients with metastatic cutaneous squamous cell carcinoma and 48% in 31 patients with locally advanced disease. The median DOR was not reached in the metastatic group, indicating that the response was durable, and most patients had not experienced disease progression at the time of data analysis. Among those with locally advanced disease, the median DOR was 17.7 months.
Ensacove for ALK-Positive NSCLCThe FDA has approved Ensacove (ensartinib) for the first-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic NSCLC. This approval is specifically for patients who have not previously received an ALK inhibitor.
A 2021 study published in JAMA Oncology demonstrated that Ensacove significantly improved PFS compared to Xalkori. The median PFS with Ensacove was 25.8 months, more than double the 12.7 months observed with Xalkori.
Ryoncil Receives FDA Approval for Children With GVHDRyoncil (remestemcel-L-rknd) was approved for children aged two months and older with steroid-refractory acute graft-versus-host disease. This is the first mesenchymal stromal cell therapy to receive FDA approval.
By day 28 of the study, the overall response rate reached 70%, with 30% of patients achieving a complete response and 41% achieving a partial response. The median DOR was 54 days, with responses lasting from seven days to at least 159 days.
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