Replimune Provides Update on RP1 Clinical Development Program in Cutaneous Squamous Cell Carcinoma
First patient enrolled in registration-directed Phase 2 clinical trial of
New clinical trial planned of
Initial clinical data with
“We are pleased to announce the initiation of our first registration-directed clinical trial for which we believe the data generated to date for
The registration-directed Phase 2 clinical trial in CSCC is a multi-center, randomized, controlled clinical trial intended to enroll approximately 240 patients. The study’s primary objective is to compare the response rate following treatment with
New Clinical Trial Planned of
“CSCC is a significant unmet medical need in organ transplant recipients, where it is the most prevalent tumor type in an immunosuppressed population already at higher risk for malignancy in general, and where anti-PD1 therapy provides a significant risk of rejection of the transplanted organ,” said
Initial Clinical Data with
The Phase 1 part of Replimune’s Phase 1/2 clinical trial of
- The first patient achieved a biopsy-confirmed complete response (CR) of extensive disease of the scalp. Clear tumor flattening was observed after the first dose of
RP1and prior to the first dose of Opdivo, prior to the patient ultimately achieving a CR. PD-L1 and CD8 T cell levels were also substantially increased post-treatment as compared to baseline (this data remains pending for the other patients).
- The second patient achieved a partial response (PR) of bulky bi-lateral disease in the neck, with substantial reduction observed after the first dose of
RP1and prior to the first dose of Opdivo, including of the uninjected tumor contralateral to the injection site.
- The third patient had extensive and rapidly progressing metastatic disease and died from disease progression within 6 weeks of starting therapy.
- The fourth patient, also with bulky disease in the neck, had a substantial reduction after the first
RP1dose, which continued to reduce following the introduction of Opdivo.
- The fifth patient, with recurrent bone invasive CSCC of the cheek, had substantial flattening after the first
RP1dose and has recently initiated the combination therapy phase with RP1and Opdivo.
- All patients other than the third patient continue on treatment.
The data from these patients can be found in the presentation linked here.
“I have been highly impressed by the initial clinical data in patients with CSCC treated with
The full Phase 1 safety, clinical efficacy and biomarker data from this clinical trial, which
CSCC is the second most common form of skin cancer and is responsible for an estimated 7,000 deaths each year in the U.S. It currently accounts for approximately 20% of all skin cancers in the U.S., with the number of newly diagnosed cases expected to rise annually. When CSCC invades deeper layers of the skin or adjacent tissues, it is categorized as locally advanced. Once it spreads to other distant parts of the body, it is considered metastatic. Libtayoâ is the only approved therapy in
About CSCC in the Organ Transplant Population
The risk of developing cancer following solid organ transplant has been reported to be between 2- and 4-fold higher than in the general population. This includes increased rates of skin cancer, Hodgkin and non-Hodgkin lymphoma, Kaposi sarcoma, and liver, lung, and thyroid cancers. The cumulative incidence of skin cancers, such as CSCC, increases with time from transplantation, with rates as high as 70% after 20 years. When compared with the general population, organ transplant recipients have a 65- to 250-fold increased risk of developing CSCC and a 2- to 8-fold risk of developing melanoma. In the clinical trials in which immune checkpoint blockade drugs have been investigated, organ transplant patients were excluded due to the potential risk of transplanted organ rejection, and as a result, safety and efficacy has not been formally studied. Safety and efficacy of immune checkpoint blockade drugs in organ transplant recipients has, however, recently been obtained from literature reports including 57 organ transplant patients (Fisher et al 2019 J. Am. Acad. Dermatol.
Forward Looking Statements
This press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding our advancement of our clinical trials, our plans to initiate new clinical trials, our goals to develop and commercialize our product candidates, our proposed scientific presentations, and other statements identified by words such as “could,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “will,” “would,” or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to our limited operating history, our ability to generate positive clinical trial results for our product candidates, the costs and timing of establishing, equipping, and operating our planned in-house manufacturing facility, the timing and scope of regulatory approvals, changes in laws and regulations to which we are subject, competitive pressures, our ability to identify additional product candidates, and other risks set forth under the heading “Risk Factors” of our Quarterly Report on Form 10-Q for the quarterended June 30, 2019. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements.
Source: Replimune Group Inc