Oncology Takes Center Stage in December 2024 Clinical Trials with Prostate and Breast Cancer Drugs Approaching Approval

As we move towards the culmination of 2024, there have been remarkable achievements in the realm of clinical trials, reflecting the evolution of medical science and the pursuit of innovation. This time period has witnessed the completion of several pivotal studies, regulatory milestones, and groundbreaking advancements across various therapeutic areas. From breakthroughs in oncology to chronic ailments like diabetes, this has been a transformative period in healthcare. Let's explore the key updates from late 2024, offering a lens on their implications for patients as well as the broader medical community.

Hope for Managing Psoriatic Arthritis as Bristol Myers Squibb's Sotyktu Demonstrates Positive Results in Phase 3 Trials

Bristol Myers Squibb, on December 23rd, 2024, announced the results from their Phase 3 Sotyktu psoriatic arthritis (PsA) program which showed the Sotyktu's efficacy and safety against active psoriatic arthritis. Sotyktu (deucravacitinib) is a selective, oral allosteric tyrosine kinase 2 (TYK2) inhibitor from a new class of small molecules. It has a unique mode of action that targets TYK2 and inhibits the signaling of interleukin (IL)-23, IL-12 and Type 1 interferons (IFN). These key cytokines are engaged in the pathogenesis of several immune-mediated diseases. The two trials had a 52-week treatment period which involved a placebo-controlled treatment period. The drug achieved the primary endpoint with the ACR20 response, wherein there was an improvement in signs and symptoms of the condition by at least 20% (after 16 weeks of treatment).

The drug was evaluated in two Phase 3 multicenter, randomized, double-blind, placebo-controlled trials, namely, POETYK PsA-1 and POETYK PsA-2. The POETYK PsA-1 trial enrolled around 670 patients with active psoriatic arthritis. These patients had not received any prior biologic disease-modifying antirheumatic drug (bDMARD naïve). POETYK PsA-2, on the other hand, enrolled approximately 730 patients with active psoriatic arthritis who had already received TNFα inhibitor treatment or were bDMARD naïve.

New Injection Enables Patients to Improve Vision Loss Associated with Macular Edema with Fewer Dosage

On December 18, 2024, Regeneron Pharmaceuticals revealed that their EYLEA HD (aflibercept) Injection 8 mg was successful in providing non-inferior vision gains to patients with macular edema following retinal vein occlusion (RVO). The primary endpoint was met in the Phase 3 QUASAR trial, a global double-masked, active-controlled Phase 3 trial. In this trial, the patients were randomized into 3 groups, wherein, the patients would receive either EYLEA HD every 8 weeks followed by 3 initial monthly doses; EYLEA HD every 8 weeks following 5 initial monthly doses; or EYLEA every 4 weeks. The data will be submitted to regulatory authorities globally, with a submission to the United States FDA anticipated in the first quarter of 2025. 

MannKind's Inhaled Insulin (Afrezza®) Clears Phase 3 Trials to Treat Pediatric Diabetes 

On December 13, 2024, MannKind Corporation announced the results of its Phase 3 INHALE-1 study that evaluated Afrezza (insulin) Inhalation Powder in children aged between 4-17 years of age. The inhalation powder is dedicated to improving glycemic control in patients with diabetes mellitus. The INHALE-1 study enrolled 230 subjects into two groups and was designed to go on for 26 weeks. The primary endpoint revolved around a non-inferior change in the HbA1c levels post-26 weeks, wherein the product under evaluation demonstrated overall efficacy and safety outcomes. Following the results of the study, the company is planning to submit an application for supplemental new drug application (sNDA) meeting with the United States Food and Drug Administration (FDA) in 2025 first half to finalize the filing timeline and data further. 

Pfizer’s IBRANCE in Combination with Standard-of-Care Therapies Shows Promising Results Against HR+, HER2+ Metastatic Breast Cancer

On December 12, 2024, Pfizer announced the outcomes from Phase 3 of its PATINA trial which underscored that the addition of IBRANCE ® (palbociclib) to the standard of care therapies demonstrated positive outcomes for the management of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (MBC) in patients. IBRANCE is the first CDK4/6 inhibitor which was evaluated in the PATINA study (sponsored by Alliance Foundation Trials, LLC). In comparison to using anti-HER2 therapy and endocrine therapy alone (when the progression free survival was only 29 months), it demonstrated a clinically significant improvement in progression free survival, raising it to 44.3 months when used in conjunction with endocrine therapy and anti-HER2 therapy (trastuzumab or trastuzumab plus pertuzumab). 

Breast cancer poses a significant threat to the population, with 1 out of every 8 women (13%) in the United States developing invasive breast cancer at some moment in their life. According to the Expert Market Research analysis, the breast cancer therapeutics market is projected to grow at a CAGR of 10.8% during the forecast period of 2025-2034 to reach a value of USD 84.22 billion by 2034. Hence, these promising results are expected to impact the treatment landscape for breast cancer positively and address the unmet needs of a wider section of the affected population.

Candel Therapeutics Announces Results from its Phase 3 Prostate Cancer Trial, Demonstrating Improved Disease-Free Survival

On 11 December 2024, Candel Therapeutics, Inc., revealed the results from its multicenter Phase 3 clinical trial, wherein, their viral immunotherapy candidate CAN-2409 showed significant improvement in prostate cancer treatment. CAN-2409 is a replication-defective adenovirus that induces the herpes simplex thymidine kinase (HSV-tk) gene in tumor cells. The investigational candidate, when administered in combination with valacyclovir, is designed to deliver exposure to tumor antigens, leading to immunogenic cell death of tumor cells. The study met its primary endpoint, demonstrating improvement in disease-free survival (DFS). The CAN-2409 treatment arm showed a 14.5% improvement in DFS compared to the treatment arm. 

The use of viral vectors in gene therapy, such as adenovirus-based vectors like CAN-2409, represents a critical innovation in the treatment of prostate cancer and other malignancies. Adeno-associated virus (AAV) vector-based gene therapy is a widely explored alternative due to its non-pathogenic nature and ability to efficiently deliver genetic material to targeted cells. Prostate cancer is one of the leading causes of morbidity across the globe. The United States alone has around 100,000 diagnosed cases of localized prostate cancer annually. Out of this, 50,000 (50%) of the men undergo radiation therapy to manage the condition. Expert Market Research analysis indicates that the metastatic prostate cancer market is expected to grow at a CAGR of 8.1% during the forecast period 2025-2034 to reach a value of USD 17 billion by 2034. Therefore, such drug responses are expected to improve patient outcomes in the coming years.

In December 2024, the clinical trials landscape showcased various innovations, with significant advancements in managing metastatic breast cancer, prostate cancer, and immune-mediated diseases like psoriatic arthritis. Oncology, in particular, remains a key area of emphasis amongst researchers, owing to the rising burden of cancer, along with greater investment into research and precision medicine. The continued expansion of personalized medicine, supported by advancements in genomics and AI-driven drug discovery, is likely to transform the pharmaceutical industry further. As we transition into 2025, the convergence of these innovations with increasing regulatory approvals and market demand indicates a transformative phase for global healthcare.

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