Anal Cancer Treatment Market Expected to Reach $1.63 Billion by 2030 as Latest Clinical Studies Focus on New Therapies

PRESS RELEASE
Published February 14, 2024

Palm Beach, FL - February 14, 2024 - FN Media Group News Commentary Recent reports project that the anal cancer market will continue its recent growth through 2030. An article on the MD Anderson website. It said: "More than 8,000 people in the U.S. are diagnosed with anal cancer each year. Due to higher rates of the human papilloma virus, a key risk factor, it affects women more than men. If found early, the disease can be successfully treated. Several types of tumors may be found in the anus. While some of them are malignant (cancer), others are benign (not cancer) or precancerous (may develop into cancer). The main types of anal cancer are: Carcinoma in situ is early cancer or precancerous cells. They are only on the surface cells of the anal canal. This also may be called Bowen's disease; Squamous cell cancer (carcinoma) forms in the cells that line the anus. This is the most common type of anal cancer; Adenocarcinomas develop in the glands around the anus; and Skin cancers, including basal cell and melanoma, often are found when they are in advanced stages. A report from Market Research Future projected that: "The Anal cancer market is anticipated to reach USD 1,638.5 Million by 2030 at 8.6% CAGR... through 2030. It said: "Anal cancer is a rare type of cancer that begins in the anus, which is the orifice at the rectums end. Anal cancer has one of the highest rates of occurrence and prevalence in the globe. Lifestyle issues, aging, and diet are thought to be the primary causes of anal cancer. According to the World Health Organization (WHO), an increase of roughly 70% in anal cancer cases is projected globally over the Anal Cancer Market Analysis period (2030). Squamous cell carcinoma, which develops from cells around or in the anal entrance or, in rare cases, in the anal canal, is the most common type of anal cancer. This malignancy is frequently linked to the human papillomavirus (HPV), with HPV malignancies or cervical cancers having a significant chance of progressing to anal cancer. Anal cancer has no specific symptoms; however, it might cause bleeding from the anal area, a tumor or swelling near the anus, or a change in bowel habits." Active biotech and pharma companies in the markets this week include Oncolytics Biotech(R) Inc. (NASDAQ: ONCY) (TSX: ONC), Exelixis, Inc. (NASDAQ: EXEL), Pfizer Inc. (NYSE: PFE), BioXcel Therapeutics, Inc. (NASDAQ: BTAI), Bristol Myers Squibb (NYSE: BMY).

The report continued: "The income earned by medications used to treat anal cancer, as well as other screening tests, kits, and medical devices used to diagnose colorectal cancer, is tracked in the study. The high spending on public health initiatives, as well as the rapid rise in global healthcare expenditure and research and development expenditure in the field of oncology, are projected to provide substantial potential prospects and increase the market size. The Americas are likely to lead the anal cancer market because of the increased prevalence of anal cancer. Europe is predicted to represent the second-largest share of the anal cancer market because of the increased prevalence of anal cancer and the presence of significant market participants. In The Middle East and Africa, due to the high incidence rate of anal cancer, the market is likely to develop gradually throughout the forecast period."

Oncolytics Biotech(R) Inc. (NASDAQ: ONCY) (TSX: ONC) Initiates Enrollment Expansion of GOBLET Anal Cancer Cohort Successful Stage 1 data showed a near tripling of Objective Response Rate compared to checkpoint inhibitor monotherapy, including a Complete Response, and supports expansion Oncolytics Biotech(R) Inc., a clinical-stage immunotherapeutics company focused on oncology, today announced the expansion of enrollment for the anal cancer cohort of the GOBLET study evaluating pelareorep in combination with atezolizumab (Tecentriq(R)) in patients with second-line or later unresectable squamous cell carcinoma of the anal canal (SCCA). The study was expanded based on positive data from Stage 1 of the study, presented at the 2nd International Multidisciplinary Anal Cancer Conference (IMACC) in November 2023 (link to the PR, link to the poster).

"These exciting clinical data, which exceed the Simon two-stage success criteria, provide strong support to expand the evaluation of pelareorep in patients with advanced anal cancer. The results reported at IMACC 2023 showed that the combination of pelareorep and atezolizumab provided a 37.5% objective response rate, including one patient with a long-lasting complete response, and good overall tolerability. These data represent a meaningful contrast to recent clinical trial results which show that patients with second-line or later anal carcinoma treated with checkpoint inhibitor therapy experienced response rates of 10-14%," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics."

"We begin the Stage 2 expansion with substantial optimism for patients and the potential of pelareorep, especially considering the initial efficacy signal observed for pelareorep-based therapy in pancreatic cancer. There is currently no established standard therapy for patients with anal carcinoma who have failed first-line treatment. Continued positive results could potentially expand the opportunity for pelareorep beyond the lead indications of breast cancer and pancreatic cancer and open the door to a rapid regulatory pathway in this rare and significantly under-served patient population," continued Dr. Coffey.

Dirk Arnold, M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg, and primary investigator of the GOBLET trial, commented, "One of the most difficult challenges in my practice is the limited number of treatment options that are available for patients with advanced anal cancer who have progressed on first-line therapy. I am enthusiastic about the expansion of this cohort because it will enable the continued evaluation of the pelareorep/atezolizumab combination and could provide important confirmatory data that may lead to better treatment options for patients with this late-stage disease."

"We look forward to building on the oncology community's enthusiastic reception of the IMACC 2023 data by expanding enrollment in the anal carcinoma cohort and incorporating additional sites into the study," commented Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "Careful consideration of recently published clinical trial results indicates that a modest expansion of fewer than 20 patients will be sufficient to solidify the efficacy signal we have observed to date and lay the groundwork for a potential future registrational study in this population. We look forward to continuing our excellent collaboration with the clinical sites and investigators at AIO and hope to report additional results in 2025." CONTINUED... Read these full press releases and more news for ONCY at: https://www.financialnewsmedia.com/news-oncy/

Other recent developments in the biotech industry of note for cancer events include:

Exelixis, Inc. (NASDAQ: EXEL) recently announced detailed results from CONTACT-02, a phase 3 pivotal study evaluating cabozantinib (CABOMETYX(R)) in combination with atezolizumab compared with a second novel hormonal therapy (NHT) in patients with metastatic castration-resistant prostate cancer (mCRPC) and measurable extra-pelvic soft tissue disease who have progressed on one prior NHT. The detailed findings are being presented during Oral Abstract Session A: Prostate Cancer at 7:55 a.m. PST on January 25 at the American Society of Clinical Oncology 2024 Genitourinary Cancers Symposium (ASCO GU).

Patients with metastatic castration-resistant prostate cancer with prior progression on a novel hormone therapy and who have measurable soft tissue metastasis experience the worst outcomes among advanced prostate cancer patients and have limited treatment options, said Neeraj Agarwal, M.D., FASCO, Senior Director for Clinical Research at Huntsman Cancer Institute at the University of Utah and the global lead investigator of the trial. CONTACT-02 is the only phase 3 study evaluating a tyrosine kinase inhibitor and an immune checkpoint inhibitor to show a statistically significant improvement in progression-free survival and a trend for overall survival in these patients. I am encouraged by these results and the potential for cabozantinib plus atezolizumab to be a widely available treatment option for our patients.

Arvinas, Inc. (ARVN) and Pfizer Inc. (NYSE: PFE) recently announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of vepdegestrant (ARV-471) for monotherapy in the treatment of adults with estrogen receptor (ER) positive/human growth epidermal growth factor 2 (HER2) negative (ER+/HER2-) locally advanced or metastatic breast cancer previously treated with endocrine-based therapy. Vepdegestrant is a novel oral PROteolysis Targeting Chimera (PROTAC(R)) ER degrader that is being jointly developed by Arvinas and Pfizer.

As described by the FDA, Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to patients earlier. Vepdegestrant as a monotherapy is being studied in the ongoing Phase 3 VERITAC-2 clinical trial, which is evaluating vepdegestrant or fulvestrant in patients with locally advanced or metastatic ER+/HER2- breast cancer who have been previously treated with an endocrine-based therapy.

BioXcel Therapeutics, Inc. (NASDAQ: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, recently announced that the U.S. Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of BXCL701 in combination with a CPI for the treatment of patients with metastatic small cell neuroendocrine prostate cancer (SCNC) with progression on chemotherapy and no evidence of microsatellite instability. The FDA grants Fast Track designation to facilitate the development and expedite the review of medicines to treat serious conditions, fill unmet medical needs, and bring promising medicines to patients more quickly. Therapies granted this designation are given the opportunity for more frequent interactions with the FDA, a rolling review, and potential eligibility for accelerated approval and priority review.

"The FDA's Fast Track designation for the investigation of BXCL701 in SCNC is an important recognition of our most advanced immuno-oncology asset and an acknowledgment of its potential to address the considerable unmet medical need in these patients. At the same time, it further validates the unique AI-based drug re-innovation approach that we used to discover this asset," said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. "BXCL701 has already demonstrated considerable potential in our clinical trials to date, and we plan to further define its development path while exploring strategic options for our OnkosXcel Therapeutics subsidiary."

Bristol Myers Squibb (NYSE: BMY) recently announced two regulatory acceptances for applications for neoadjuvant Opdivo (nivolumab) with chemotherapy followed by surgery and adjuvant Opdivo for the perioperative treatment of resectable stage IIA to IIIB non-small cell lung cancer (NSCLC). The U.S. Food and Drug Administration (FDA) accepted the supplemental Biologics Application (sBLA) and assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 8, 2024. In late January, the European Medicines Agency (EMA) validated the type II variation application which confirms the submission is complete and begins the start of the EMAs centralized review process.

Between 30% to 55% of non-small cell lung cancer patients who undergo surgery will experience disease recurrence. We are working to expand options that improve outcomes for patients with resectable disease, as part of our comprehensive approach to the treatment of multiple types of cancer, including and especially in earlier stages, said Abderrahim Oukessou, M.D., vice president, thoracic cancers global program lead, Bristol Myers Squibb. With CheckMate -77T, we have evaluated the potential for neoadjuvant immunotherapy to induce pathological complete response and the role of perioperative Opdivo treatment in reducing the likelihood that the cancer will return and help make extended survival possible for patients. The acceptance of these applications underscores our impactful progress in addressing unmet needs across several non-small cell lung cancer treatment settings and brings us one step closer to offering a new perioperative Opdivo-based regimen to patients who may benefit.

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