Palm Beach, FL – February 22, 2023 – FinancialNewsMedia.com News Commentary  – Acute myeloid leukemia (AML) is the second most common type of leukemia diagnosed in adults and children. Leukemia is a type of cancer that mainly occurs in white blood cells. White blood cells function for the immune system and are produced in the bone marrow. In the case of leukemia, the bone marrow produces abnormal white blood cells. There are different types of leukemia based on their growth of the cells, namely acute (slow-growing) and chronic (fast-growing). Based on their growth in cells, they are classified as myeloid cells or lymphoid cells. Acute myeloid leukemia occurs in the bone marrow and rapidly spreads, affecting different parts of the body such as the liver, spleen, central nervous system, lymph nodes, and testicles.  A report from iHealth Analyst projected that the global market for acute myeloid leukemia anticipated to reach $3.2 billion by 2029, growing at CAGR 9.1% over the forecast period, driven by introduction of high-priced products, and strong pipeline of upcoming candidates.  Another report from Fortune Business Insights added: “The rising prevalence of acute myeloid leukemia and unmet needs of the patients have resulted in an increased focus on the development of new drugs. New drug approvals for the acute myeloid leukemia treatment… are expected to drive the growth of global acute myeloid leukemia treatment market.”  Active biotech and pharma companies in the markets this week include Actinium Pharmaceuticals, Inc. (NYSE: ATNM), AstraZeneca PLC (NASDAQ: AZN), Bristol Myers Squibb (NYSE: BMY), Ambrx Biopharma Inc. (NYSE: AMAM), GSK plc (NYSE: GSK).

“The rise in incidences of genetic mutations, sedentary lifestyles, high exposure to radiations are some factors leading to an increased incidence in acute myeloid leukemia globally.  Moreover, the presence of potential pipeline candidates, new product launch, and increased investment by the pharmaceutical industry and research institutes are also expected to boost the market in the forecast duration.  North America is anticipated to hold a considerable share in the global acute myeloid leukemia treatment market during the forecast period due to the increasing demand, favorable health reimbursement, and strategic research collaborations. The acute myeloid leukemia treatment market in Europe is expected to expand owing to the active government support, increasing prevalence of the disease, and emphasis on early cancer diagnosis by government.”

Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) BREAKING NEWS:  Actinium Announces Positive Full Data Results From the Pivotal Phase 3 SIERRA Trial in Patients with Active, Relapsed or Refractory Acute Myeloid Leukemia – Actinium Pharmaceuticals, Inc.  (“Actinium” or the “Company”) a leader in the development of targeted radiotherapies, announced positive results for the primary and secondary endpoints from its pivotal Phase 3 SIERRA trial of Iomab-B in patients age 55 and above with active relapsed or refractory acute myeloid leukemia (r/r AML). Iomab-B met the primary endpoint of durable Complete Remission (dCR) of 6-months following initial complete remission following BMT with a high degree of statistical significance (p<0.0001). Additionally, Iomab-B produced a significant and clinically meaningful improvement in the secondary endpoint of Event-Free Survival (EFS), with a 78% reduction in the probability of an event (Hazard Ratio=0.22, p<0.0001). Iomab-B doubled 1-year survival compared to the control arm excluding cross over patients (26.1% vs 13.1%) as well as median overall survival (6.4 months vs. 3.2 months). Iomab-B was well tolerated with four times lower rates of sepsis (6.1% vs 28.6%) and lower rates of febrile neutropenia, mucositis and acute graph versus host disease (aGVHD). Iomab-B enabled unprecedented access to BMT with 100% engraftment in patients receiving a therapeutic dose of Iomab-B compared to 18% of patients in the control arm and Iomab-B produced a 75% post-BMT Complete Remission (CR) rate compared to 6.3% post-BMT CR in the control arm. These high rates of access and post-BMT CR enabled the highly significant primary endpoint results. The full SIERRA results were presented in the late-breaker session at the 2023 Tandem Meetings: Transplantation & Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR).

Dr. Sergio Giralt , Deputy Head, Division of Hematologic Malignancies, Attending Physician, Adult BMT Service at Memorial Sloan Kettering Cancer Center, stated, “The SIERRA trial results are an exciting advancement for older patients with active r/r AML and will be practice changing in how we treat these patients. I am thrilled to see a high percentage of Iomab-B patients who achieved durable remissions reaching the critical 2-year survival mark. Significant improvement in event-free survival and overall survival, with an excellent safety profile in the SIERRA trial, demonstrate the potential of Iomab-B becoming a new standard of care for active, r/r AML.”

SIERRA Trial Results – The pivotal Phase 3 SIERRA trial is a 153-patient, randomized, multi-center, controlled trial, where Iomab-B is compared to the control arm that allowed physician’s choice of over 20 available agents including chemotherapies and/or targeted therapies such as Venetoclax (Bcl-2), FLT3 inhibitors, IDH inhibitors and Mylotarg. The control arm reflects current best practices for the treatment of r/r AML patients. SIERRA was conducted at 24 of the leading BMT centers in the United States and Canada . SIERRA enrolled older, heavily pre-treated patients with active disease and high-risk characteristics who would not be offered BMT in standard practice outside of a clinical trial and therefore have dismal survival outcomes of two to three months.   Iomab-B Patient Characteristics:  Patients with active, r/r disease, Median age: 64 (55-77), Intermediate and adverse cytogenetics and molecular risk: >90%, Majority of patients had primary induction failure or first early relapse: 78%, Median blast count: 30%, Prior lines of treatment: 3 (1-8)  –  Read this full release and more news for ATNM at:  https://www.financialnewsmedia.com/news-atnm/     

Other recent developments in the biotech industry include:

Ambrx Biopharma Inc. (NYSE: AMAM) recently announced encouraging initial data from its ongoing Phase 1 trial (APEX-01 (NCT04662580)) investigating ARX517, Ambrx’s proprietary anti-PSMA ADC, in prostate cancer patients. APEX-01 is a Phase 1, first-in-human, open label dose escalation and dose expansion trial enrolling patients with advanced prostate cancer whose tumors have progressed on at least two prior FDA-approved treatments. APEX-01 is the only ongoing clinical trial in the United States targeting PSMA with an ADC. APEX-01 opened for enrollment July 2021 and this is the first data being reported in the study.

In the Phase 1 dose-escalation portion of the study, ascending dose levels of ARX517 is administered as a single agent every 3 weeks. The primary endpoints are safety, tolerability and pharmacokinetics. The key secondary endpoint is objective decline of prostate-specific antigen (PSA) from baseline and/or tumor shrinkage. PSA is a protein produced by the prostate gland and is commonly used as a biomarker to diagnose and follow prostate cancer. A ≥ 50% reduction in PSA levels from baseline is considered clinically relevant and has been shown to correlate with improved overall survival in prostate cancer.

Bristol Myers Squibb (NYSE: BMY) recently announced three-year follow-up results from the Phase 3 CheckMate -274 trial, demonstrating significant sustained clinical benefits with Opdivo (nivolumab) for the adjuvant treatment of patients with surgically resected, high-risk muscle-invasive urothelial carcinoma. With a median follow-up of 36.1 months (31.6 months minimum), djuvant Opdivo continued to show improved disease-free survival (DFS), non-urothelial tract recurrence-free survival (NUTRFS), distant metastasis-free survival (DMFS) and second progression-free survival (PFS2) compared to placebo across all-randomized patients and in patients whose tumor cells express PD-L1 ≥1%. These updated results will be featured in a late-breaking oral presentation at the American Society of Clinical Oncology (ASCO) 2023 Genitourinary Cancers Symposium from February 16-18, 2023.

“Patients with muscle-invasive urothelial carcinoma face a high chance of recurrence due to micrometastatic disease, especially within the first three years after surgical removal of the bladder or kidney. The three-year results from CheckMate -274 show a stable decrease in the risk of disease with adjuvant nivolumab with longer follow-up,” said Matthew D. Galsky,* M.D., Professor of Medicine, Director of Genitourinary Medical Oncology, Associate Director for Translational Research, and Co-Director of the Center of Excellence for Bladder Cancer at The Tisch Cancer Institute and the Icahn School of Medicine at Mount Sinai. “Nivolumab remains the only immunotherapy, as well as the only medical treatment in general, to decrease the risk of urothelial cancer recurrence after radical surgery in patients who received chemotherapy prior to surgery or who are ineligible for chemotherapy. The results of this trial have changed the way that urothelial cancer is treated.”

AstraZeneca PLC (NASDAQ: AZN) recently said results from the final prespecified overall survival (OS) analysis of the PROpel Phase III trial in metastatic castration-resistant prostate cancer (mCRPC) showed LYNPARZA^® (olaparib), jointly developed and commercialized by AstraZeneca and Merck & Co., Inc., known as MSD outside the US and Canada in combination with abiraterone and prednisone or prednisolone demonstrated median OS of 42.1 months versus 34.7 months for abiraterone plus placebo. This result represents a 7.4-month absolute difference in median OS versus a standard of care (47.9% maturity, hazard ratio [HR] of 0.81, 95% confidence interval [CI] 0.67-1.00; p=0.0544).

While this numerical increase in median OS did not achieve statistical significance, this clinical activity builds on the meaningful survival gains achieved for patients in this setting treated with abiraterone alone, a current standard of care. Results will be presented today in an oral presentation at the 2023 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium (#LBA16).

GSK plc (NYSE: GSK) recently reported that the US Food and Drug Administration (FDA) granted full approval for Jemperli (dostarlimab-gxly) for the treatment of adult patients with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer, as determined by a US FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.

Hesham Abdullah, Senior Vice President, Global Head of Oncology Development, GSK, said: “This US regulatory action confirms our confidence in Jemperli as an important treatment option for patients with dMMR recurrent or advanced endometrial cancer. We continue to unlock the potential of Jemperli as the backbone for our immuno-oncology development programs to address the unmet needs of patients, including earlier lines of endometrial cancer and other solid tumors.”

In April 2021, Jemperli received accelerated approval for the treatment of adult patients with dMMR recurrent or advanced endometrial cancer that had progressed on or following prior treatment with a platinum-containing regimen.

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