Hanmi Pharmaceutical and Eli Lilly and Company Join Forces to Advance Sonefpeglutide Development; Johnson & Johnson’s ERLEADA Achieves Positive Phase 3 Outcomes; Revolution Medicines Unveils Landmark Phase 3 RASolute 302 Data Demonstrating Strong Efficacy of Daraxonrasib in Metastatic Pancreatic Cancer; Pfizer’s BRAFTOVI Treatment Advances Outcomes by Nearly Doubling Progression-Free Survival in mCRC; Imfinzi Sets a New Standard with US Approval of the Only Immunotherapy Combination for BCG-Naïve High-Risk Bladder Cancer

Hanmi Pharmaceutical Secures Licensing Agreement with Eli Lilly and Company for Sonefpeglutide 

Hanmi Pharmaceutical announced a licensing agreement with Eli Lilly and Company covering the development, manufacturing, and commercialization of sonefpeglutide (LAPSGLP-2 analog), Hanmi’s investigational biologic therapy.

Sonefpeglutide is based on Hanmi’s proprietary long-acting drug delivery platform, LAPSCOVERY™. The company has previously secured FDA approval for a biologic utilizing this technology and is advancing several additional global clinical programs built on the same platform.

Hanmi has extensively investigated the therapeutic properties of glucagon-like peptide-2 (GLP-2), including its ability to stimulate intestinal growth, reduce inflammation, and support intestinal mucosal repair and regeneration. These findings have been demonstrated in multiple preclinical studies, and the potential applications of LAPSGLP-2 have been highlighted at various international scientific meetings. The candidate is currently being evaluated in a global Phase II study for short bowel syndrome (SBS).

Under the terms of the agreement, Hanmi will complete the ongoing global Phase II SBS trial, while Lilly will assess opportunities to expand the clinical development of sonefpeglutide based on existing preclinical and clinical evidence.

The partnership grants Lilly exclusive worldwide rights to develop, manufacture, and commercialize sonefpeglutide, except in South Korea, where rights remain excluded from the agreement. Under the terms of the agreement, Hanmi will receive an upfront payment of USD 75 million and could earn up to USD 1.185 billion in additional payments tied to clinical development, regulatory approvals, and commercial milestones. The company will also be entitled to royalties on future product sales following commercialization.

Johnson & Johnson Reports Landmark Phase 3 Results for ERLEADA in Localized Prostate Cancer

Johnson & Johnson reported positive final results from the Phase III PROTEUS trial, demonstrating that the investigational use of apalutamide in combination with androgen deprivation therapy (ADT), administered for six months before and after radical prostatectomy, significantly improved both short- and long-term outcomes in patients with high-risk localized or locally advanced prostate cancer. The study successfully achieved its co-primary endpoints, with patients receiving the apalutamide-based regimen showing a substantially higher rate of pathologic complete response or minimal residual disease at surgery compared with ADT alone (8.9% vs. 1.0%). Additionally, the combination therapy lowered the risk of metastasis or death by 20% and delayed the need for subsequent treatment beyond six years. These findings are being presented during a plenary session at the 2026 Annual Meeting of the American Society of Clinical Oncology and published concurrently in The New England Journal of Medicine.

Radical prostatectomy remains a standard treatment option for patients with high-risk localized or locally advanced prostate cancer, alongside radiation therapy. However, disease recurrence occurs in nearly half of patients following curative-intent surgery, often necessitating additional treatment and reducing the likelihood of achieving a cure. Current treatment strategies frequently introduce intensified therapies only after metastatic progression, potentially missing an earlier opportunity to improve long-term clinical outcomes.

Apalutamide is an androgen receptor inhibitor designed to block the binding of androgen hormones to their receptor, thereby suppressing prostate cancer growth and progression. The therapy is already approved for several advanced prostate cancer settings, including metastatic castration-sensitive prostate cancer and non-metastatic castration-resistant prostate cancer.

Revolution Medicines Highlights Practice-Changing Phase 3 RASolute 302 Findings for Daraxonrasib at ASCO Plenary Presentation

Revolution Medicines, a late-stage oncology-focused biotechnology company advancing precision therapies for patients with RAS-dependent cancers, has announced comprehensive findings from its global Phase III RASolute 302 study evaluating daraxonrasib, an oral RAS(ON) multi-selective inhibitor, in previously treated patients with metastatic pancreatic ductal adenocarcinoma (PDAC). The results are being showcased in a late-breaking plenary presentation at the 2026 ASCO Annual Meeting and have simultaneously been published in The New England Journal of Medicine.

RAS serves as a critical regulator of cellular growth and is recognized as the predominant oncogenic driver in PDAC. The disease is often marked by persistent RAS(ON) pathway activation, regardless of whether tumors harbor a detectable RAS mutation. Daraxonrasib represents the first investigational therapy from a new class of RAS(ON) multi-selective inhibitors developed to target a broad range of RAS variants. In the Phase III RASolute 302 trial, once-daily daraxonrasib achieved significant improvements in both overall survival (OS) and progression-free survival (PFS) compared with standard cytotoxic chemotherapy in patients with previously treated metastatic PDAC, irrespective of tumor RAS mutation status. The study successfully met all primary and key secondary endpoints.

In addition to its efficacy benefits, daraxonrasib demonstrated a manageable safety profile. Patients receiving the therapy experienced a significantly longer time before deterioration in cancer-related pain, overall health status, and quality of life compared with those treated with chemotherapy.

Commenting on the results, Mark A. Goldsmith stated that the company has remained committed to developing transformative targeted treatments for RAS-driven malignancies, among the most challenging cancers in oncology. He noted that the positive Phase III findings validate the company’s scientific strategy and further strengthen the evidence supporting the broad therapeutic potential of RAS(ON) inhibition across pancreatic cancer and other RAS-driven tumors.

Pfizer’s BRAFTOVI-Based Therapy Significantly Extends Progression-Free Survival in Metastatic Colorectal Cancer

Pfizer recently announced comprehensive progression-free survival (PFS) and overall survival (OS) findings from Cohort 3 of the Phase III BREAKWATER study, which assessed BRAFTOVI (encorafenib) in combination with cetuximab (ERBITUX®) and FOLFIRI chemotherapy compared with FOLFIRI, with or without bevacizumab, in treatment-naïve patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC). The data were presented in a late-breaking session at the 2026 ASCO Annual Meeting and concurrently published in the Annals of Oncology.

The trial had previously achieved its primary endpoint of objective response rate (ORR), as determined by blinded independent central review (BICR). Newly presented results demonstrated that the BRAFTOVI-based regimen significantly improved progression-free survival, extending median PFS to 15.2 months compared with 8.3 months in the control arm. This translated into a 56% reduction in the risk of disease progression or death (HR=0.44; 95% CI: 0.27–0.70; p=0.0002).

Updated overall survival data further highlighted the regimen’s clinical benefit. With a median follow-up of approximately 20 months, patients receiving the BRAFTOVI combination experienced a 44% lower risk of death compared with those in the comparator group (HR=0.56; 95% CI: 0.34–0.94). At 18 months, the estimated survival rate was 72% for patients treated with the BRAFTOVI regimen versus 54.5% for those receiving standard therapy. Median overall survival had not yet been reached in the BRAFTOVI arm, while it was 20.3 months in the comparator arm.

Supported by the collective evidence from the Phase III BREAKWATER program, including Cohort 3, the U.S. FDA granted full approval in February 2026 for BRAFTOVI in combination with cetuximab and fluorouracil-based chemotherapy for patients with BRAF V600E-mutant mCRC, broadening treatment options and allowing flexibility in chemotherapy selection.

To improve accessibility of scientific data, Pfizer has also developed Abstract Plain Language Summaries (APLS) for its research presentations. These summaries translate complex clinical findings into easier-to-understand language and are available through Pfizer’s dedicated APLS platform.

Imfinzi Receives US Approval as the First and Only Immunotherapy Combination for BCG-Naïve High-Risk NMIBC Patients

AstraZeneca’s Imfinzi (durvalumab), when combined with Bacillus Calmette-Guérin (BCG) induction and maintenance therapy, has received US approval for the treatment of adults with BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC). This marks the first approved immunotherapy-based combination regimen for this patient population in the United States.

The approval from the US Food and Drug Administration (FDA) was supported by findings from the Phase III POTOMAC trial, which were presented at the 2025 European Society for Medical Oncology (ESMO) Congress and concurrently published in The Lancet. In 2024, more than 31,000 patients in the US received treatment for high-risk NMIBC, a disease setting typically managed with tumor resection followed by intravesical BCG therapy. Despite standard treatment, a substantial proportion of patients remain at risk of recurrence or disease progression, with recurrence rates reaching as high as 80% within five years.

Data from the POTOMAC study demonstrated that adding Imfinzi to BCG induction and maintenance therapy reduced the risk of high-risk disease recurrence, progression, or death by 32% compared with BCG alone (DFS hazard ratio: 0.68; 95% CI: 0.50–0.93; p=0.0154). After a median follow-up of 60.7 months, the combination regimen showed an early and durable disease-free survival benefit, with separation between treatment arms emerging within four months of treatment initiation. Median disease-free survival had not yet been reached in either study arm.

The safety profile of Imfinzi plus BCG was consistent with the known characteristics of each therapy, and no new safety concerns emerged during long-term follow-up. Importantly, the addition of Imfinzi did not interfere with patients’ ability to complete BCG treatment and had no meaningful effect on quality-of-life outcomes.

Based on the POTOMAC results, regulatory applications are currently under review in the European Union, Japan, and several other regions. AstraZeneca continues to expand Imfinzi’s role across bladder cancer settings. Recently announced results from the Phase III VOLGA trial showed that perioperative Imfinzi combined with neoadjuvant enfortumab vedotin significantly improved event-free survival and overall survival in patients with muscle-invasive bladder cancer (MIBC) who were unsuitable for or declined cisplatin-based chemotherapy. Additionally, Imfinzi plus Imjudo (tremelimumab) and enfortumab vedotin demonstrated a significant event-free survival benefit, while overall survival results remain under further evaluation.

Imfinzi is already approved in multiple countries for cisplatin-eligible MIBC based on results from the Phase III NIAGARA trial and is currently being further evaluated in locally advanced and metastatic bladder cancer through the ongoing Phase III NILE study.