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Opdivo® Intravenous Infusion Approved in South Korea in Combination with Cisplatin and Gemcitabine for the First-Line Treatment of Patients with Unresectable or Metastatic Urothelial Carcinoma

On July 18, 2024 Ono Pharmaceutical Co., Ltd. reported that Ono Pharma Korea Co., Ltd. ("OPKR"), a Korean subsidiary of Ono, received the additional approval of Opdivo (nivolumab) Intravenous Infusion ("Opdivo"), an anti-PD-1 antibody, in combination with cisplatin and gemcitabine on July 17 from the Ministry of Food and Drug Safety (MFDS) in South Korea, for the first-line treatment of patients with unresectable or metastatic urothelial carcinoma (Press release, Ono, JUL 18, 2024, View Source [SID1234646252]).

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This approval is based on results from the Phase 3 CheckMate -901 study (CA209-901: ONO-4538-56), evaluating Opdivo in combination with cisplatin and gemcitabine followed by Opdivo monotherapy, compared to cisplatin-gemcitabine alone, in patients with previously untreated unresectable or metastatic urothelial carcinoma (UC). In this study, Opdivo in combination with cisplatin and gemcitabine followed by Opdivo monotherapy demonstrated statistically significant and clinically meaningful improvements in the primary efficacy endpoints of overall survival (OS) and progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR), compared to chemotherapy alone. The safety profile of the regimens in this study was consistent with the known safety profiles of the individual components of the regimen. No new safety concerns were identified

With respect to the indication of UC, Opdivo monotherapy was approved in South Korea for the treatment of "locally advanced or metastatic urothelial carcinoma that has progressed on or following platinum-based chemotherapy" in August 2017, and "adjuvant treatment in patients with muscle-invasive bladder carcinoma (MIBC) at a high risk of recurrence after undergoing radical resection" in February 2022.

About CheckMate -901 Study (CA209-901: ONO-4538-56)
CheckMate -901 is a randomized, open-label Phase 3 study, evaluating Opdivo in combination with Yervoy (ipilimumab) (primary study) or Opdivo in combination with cisplatin and gemcitabine followed by Opdivo monotherapy (sub-study) compared to standard-of-care cisplatin-gemcitabine alone, in patients with previously untreated unresectable or metastatic urothelial carcinoma.
In the CheckMate -901 study, cisplatin-eligible patients were randomized to receive either Opdivo 360 mg in combination with cisplatin-gemcitabine every three weeks for up to six cycles followed by Opdivo 480 mg monotherapy every 4 weeks until disease progression or unacceptable toxicity up to a maximum of two years, or cisplatin-gemcitabine alone every three weeks for up to six cycles. The primary endpoints of this study were overall survival (OS) and progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR). The OS and PFS outcomes are based on the final efficacy analyses of these endpoints.
The primary study is ongoing to assess Opdivo plus Yervoy versus standard-of-care chemotherapy.

About Urothelial Carcinoma
Bladder cancer is the ninth most common cancer in the world, with more than 610,000 new cases diagnosed in 2022 and more than 220,000 people die from it each year. Urothelial carcinoma, which most frequently begins in the cells that line the inside of the bladder, accounts for approximately 90% of bladder cancer cases. In addition to the bladder, urothelial carcinoma can occur in other parts of the urinary tract, including the ureters and renal pelvis. The majority of urothelial carcinomas are diagnosed at an early stage, but rates of recurrence and disease progression are high. Approximately 50% of patients who undergo radical surgery will experience disease recurrence, especially within the first two to three years after surgical removal of the bladder or kidney. For patients whose disease recurs as metastatic cancer, the prognosis is poor, with a median overall survival of approximately 12 to 14 months when treated with systemic therapy.

About Opdivo
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response by blocking the interaction between PD-1 and its ligands. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers since the approval for the treatment of melanoma in Japan in July 2014. Opdivo is currently approved in more than 65 countries, including Japan, South Korea, Taiwan, the US and European Union.
In Japan, Ono launched Opdivo for the treatment of unresectable melanoma in September 2014. Thereafter, Opdivo received an approval for additional indications of unresectable, advanced or recurrent non-small cell lung cancer in December 2015, unresectable or metastatic renal cell carcinoma in August 2016, relapsed or refractory classical Hodgkin lymphoma in December 2016, recurrent or metastatic head and neck cancer in March 2017, unresectable advanced or recurrent gastric cancer which has progressed after chemotherapy in September 2017, unresectable advanced or recurrent malignant pleural mesothelioma which has progressed after chemotherapy in August 2018, microsatellite instability high (MSI-High) unresectable advanced or recurrent colorectal cancer that has progressed following chemotherapy and unresectable advanced or recurrent esophageal cancer that has progressed following chemotherapy in February 2020, cancer of unknown primary in December 2021, adjuvant treatment of urothelial carcinoma in March 2022, malignant mesothelioma (excluding malignant pleural mesothelioma) in November 2023, and unresectable advanced or recurrent malignant epithelial tumors in February 2024.
In addition, Ono has been conducting clinical development program including hepatocellular carcinoma, ovarian cancer, etc.

About Ono and Bristol Myers Squibb Collaboration
In 2011, through a collaboration agreement with Bristol Myers Squibb (BMS), Ono granted BMS its territorial rights to develop and commercialize Opdivo globally except in Japan, South Korea and Taiwan, where Ono had retained all rights to Opdivo except the US at the time. In July 2014, Ono and BMS further expanded their strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agent and combination regimens – for patients with cancer in Japan, South Korea and Taiwan.

First half of 2024: Boehringer Ingelheim progresses pipeline at pace and reaches major milestones

On July 18, 2024 Boehringer Ingelheim, a leading research-driven biopharmaceutical company, reported significant progress in its pipeline across key therapeutic areas as it reached major milestones in the first half of the year (Press release, Boehringer Ingelheim, JUL 18, 2024, View Source [SID1234646116]).

"We are stepping up our investments in R&D beyond our plans announced in April," said Hubertus von Baumbach, Chairman of the Board of Managing Directors. "The data read-outs that we received in MASH and will receive for oncology, mental health, and pulmonary fibrosis give us reason to accelerate our launch preparedness for these late-stage assets. We are pleased to see our pipeline developing at such pace."

Boehringer advanced its pipeline across clinical phases with five new phase I, II, or III initiations in cardiometabolic diseases, mental health, and oncology, and achieved two additional fast track designations for programs in inflammation. At the same time, the company announced nine R&D partnership agreements, significantly bolstering its human pharma portfolio across all therapeutic areas and tech platforms.

"As our pipelines continue to expand, both in depth and breadth, we need to apply a rigorous focus where we allocate our resources," said Frank Hübler, Member of the Board of Managing Directors with responsibility for Finance. "We want to accelerate our pipeline where we can, to deliver innovative medicines to patients ever faster."

Net sales rose by 7.4%* year-on-year to EUR 12.9 billion in the first six months of 2024, driven by ongoing high patient demand for Boehringer’s medications, especially for the JARDIANCE product family and OFEV in Human Pharma, and NEXGARD in Animal Health.

Human Pharma
As Boehringer prepares for its future portfolio and ongoing and upcoming launches, the past months were marked by developments across all focus therapy areas. For the remainder of the year, more news is expected across the portfolio with data read-outs in oncology (Zongertinib), mental health (Iclepertin) and pulmonary fibrosis (Nerandomilast).

The company’s efforts to advance holistic cardiovascular, renal and metabolic (CRM) health met some major milestones. Positive Phase II data for survodutide in metabolic dysfunction-associated steatohepatitis (MASH) showed groundbreaking results in liver disease due to MASH, with 83.0% of adults treated with survodutide achieving significant improvements versus 18.2% for placebo (response difference: 64.8%; CI 51.1%-78.6%, p<0.0001). Also, a sub analysis demonstrated that up to 64.5% of adults with fibrosis stages F2 and F3 (moderate to advanced scarring) achieved an improvement in fibrosis without worsening of MASH vs placebo, 25.9% [response difference: 38.6% (95% CI 18.1% – 59.1%), p=0.0005].1

The company initiated a Phase III trial in chronic heart failure for its novel selective aldosterone synthase inhibitor (ASi) in combination with empagliflozin. In an upcoming Phase III trial in chronic kidney disease for ASi, Boehringer will collaborate with Oxford Population Health.

Boehringer has joined a multi-year sponsorship of the American Heart Association’s Cardiovascular-Kidney-Metabolic Health Initiative. The initiative, which was announced recently, will allow the company to better understand the burden of people affected by diseases in these interconnected areas and enable better care.

Boehringer is committed to re-entering oncology with targeted investments. Phase Ia/Ib trial of Zongertinib, a HER2-specific tyrosine kinase inhibitor in patients with HER2 aberration-positive solid tumors, showed that Zongertinib was well tolerated and demonstrated promising efficacy. 2 The Brightline-1 trial investigating Brigimadlin in dedifferentiated liposarcoma did not meet its primary endpoint, though the benefit-risk assessment remains positive. Data for both oncology trials will be presented at conferences in the coming months.

In the first six months of 2024, the Human Pharma business grew by 9.3%* year on year. Net sales stood at EUR 10.3 billion. Growth was driven primarily by the JARDIANCE family and OFEV. To meet growing demand, the company continues high investments in its production and supply network. In January, Boehringer announced a further expansion and upgrade of its plant in Koropi, Greece. With an investment of EUR 120 million, the company will increase the manufacturing capacity of new and existing medications, some of them in the late-stage development.

Animal Health
In livestock, the VAXXITEK portfolio of poultry vaccines continues to expand and grew by 15.9%*. The company launched BULTAVO 3, a new vaccine that protects cattle and sheep against bluetongue virus serotype 3 (BTV-3). It is the first BTV-3 vaccine that prevents clinical signs and mortality. BULTAVO 3 has been licensed for emergency use in the Netherlands, Belgium, and Germany. Recent outbreaks of BTV-3 in the three countries caused severe losses for farmers and are threatening neighboring countries.

In the Animal Health business, growth was slower than expected in the first six months, with sales up 0.9%* compared to the same period last year to EUR 2.5 billion. This was primarily due to lower-than-expected sales in the U.S. pet business and challenging market conditions in China, especially impacting the swine vaccine business. Most other markets delivered solid growth.

With the recent launches of NEXGARD PLUS for dogs and NEXGARD COMBO for cats, sales of the NEXGARD parasiticides brands grew by 15.9%*. FRONTPRO, the first approved over-the-counter chewable tablet against ticks and fleas for dogs, is now available in most countries in Europe and continues to drive growth in the region. In pet therapeutics, sales of VETMEDIN, indicated for use in dogs with congestive heart failure, grew by 16.1%*.

Pipeline Outlook
Looking ahead, the company aims for up to 25 new treatment launches in Human Pharma until 2030. In Animal Health, 20 additional launches are expected across markets until 2026, including product updates, indication expansion and new products.

Novartis Second Quarter and Half Year 2024

On July 18, 2024 Novartis reported the Second Quarter and Half Year 2024 (Presentation, Novartis, JUL 18, 2024, View Source [SID1234645117]).

BriaCell Quadruples Progression Free Survival (PFS) in Patient with “Eye-Bulging” Metastatic Breast Cancer

On July 18, 2024 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported significantly higher PFS for its top responder patient in the Phase 2 study of BriaCell’s Bria-IMT regimen in combination with an immune checkpoint inhibitor in metastatic breast cancer (Press release, BriaCell Therapeutics, JUL 18, 2024, View Source [SID1234645084]). The patient remains alive and she continues to receive BriaCell’s treatment regimen.

"We are extremely pleased with the unprecedented survival benefit in this very-difficult-to-treat patient," stated Dr. William V. Williams, BriaCell’s President and CEO. "This data represents a step forward in our efforts to build on our knowledge and successes to transform cancer care for patients. We expect to replicate this positive data in our ongoing Phase 3 study and bring relief to cancer patients whose medical needs remain unmet."

"Despite recent advances in cancer therapy, metastatic breast cancer remains an unmet medical need, as current treatments are limited by poor survival and harsh side effects," commented Dr. Giuseppe Del Priore, BriaCell’s Chief Medical Officer. "The Bria-IMT regimen produced a much longer than expected survival benefit in addition to its favorable safety and tolerability in this patient suggesting its potential as a therapeutic option for these cancer patients."

The patient had a large right orbital lesion (behind the right eye) and a right temporal lobe lesion (in the right side of the brain). The temporal lobe lesion is no longer detectable, while the orbital lesion has continued to shrink markedly (see figure showing resolution of proptosis post treatment (small arrows) with reduction in tumor indicated by the large arrows). In addition, her tumor markers (blood tests that correlate with the amount of tumor in the body) have markedly decreased from her pre-treatment levels.

Haystack Oncology and Lisata Therapeutics Initiate Research Collaboration to Use the Haystack MRD™ Technology to Evaluate Efficacy of Pancreatic Cancer Therapy

On July 18, 2024 Haystack Oncology, a Quest Diagnostics (NYSE: DGX) company, and Lisata Therapeutics, Inc. (Nasdaq: LSTA), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, reported a research collaboration (Press release, Lisata Therapeutics, JUL 18, 2024, View Source [SID1234645015]). Lisata will deploy the highly sensitive Haystack MRD technology for the detection of circulating tumor DNA (ctDNA) in a clinical study evaluating certepetide plus chemotherapy as an investigational treatment for metastatic pancreatic cancer.

In the FORTIFIDE study, Lisata is investigating the safety, tolerability, and efficacy of its lead product candidate, certepetide, when given as a 4-hour continuous infusion in combination with standard-of-care treatment in subjects with metastatic pancreatic ductal adenocarcinoma (mPDAC) who have progressed on FOLFIRINOX, a treatment for pancreatic cancer. As part of this research, Lisata has engaged Haystack to use its MRD technology to measure serum ctDNA levels at multiple timepoints in patients throughout the study as an exploratory endpoint for analyzing the early therapeutic effect of certepetide. Certepetide is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to target and penetrate solid tumors more effectively.

"Our collaboration with Lisata underscores the value of our Haystack MRD technology in helping to drive forward the development of novel treatments for solid tumor cancers," said Dan Edelstein, Vice President and General Manager of Haystack Oncology. "Haystack’s technology was engineered to detect ctDNA with exceptional sensitivity, and we aim to continue to gain insights into ctDNA kinetics via serial measurements as an important and early indication of therapeutic response."

The American Cancer Society estimates more than 66,000 individuals nationwide will be diagnosed with pancreatic cancer in 2024. mPDAC accounts for more than 90% of pancreatic cancer cases and is a highly aggressive form of the disease. Typically, mPDAC advances to this stage because of a lack of early diagnosis or limited patient response to treatments.1

"A significant challenge in the development of anti-cancer therapies for pancreatic tumors is the early measurement of response to treatment. Most clinical trials evaluating pancreatic cancer require waiting for long-term survival outcomes to discern treatment effect," said Kristen K. Buck, M.D., Executive Vice President of R&D and Chief Medical Officer of Lisata. "Conventional response assessment via imaging may lack sensitivity in certain situations, and highly sensitive ctDNA assays offer the potential to quickly identify clinically meaningful biologic activity in difficult to treat cancers. The Haystack MRD test has the level of sensitivity required for us to better identify the selective tumor penetrating effect of certepetide, our lead candidate, for the treatment of solid tumors."