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Medscape
7 days ago
- Health
- Medscape
You Can Manage Pulmonary Embolism in Primary Care
About 900,000 people are affected by pulmonary embolism (PE) each year in the United States, according to the American Lung Association and about 100,000 people die each year as a result of the disorder. However, some patients diagnosed with PE may be at low risk for adverse outcomes, and some experts suggest primary care physicians (PCPs) can effectively manage these low-risk patients. According to some research, it's both possible and feasible. Another potential benefit: Research also suggests that outpatient treatment for low-risk patients could reduce the burden on the healthcare system while reducing costs. Detailed Assessment to Determine 'Low Risk' The concept of treating low-risk patients with PE at home is not new. A 2022 study in the Journal of General Internal Medicine described how 652 patients diagnosed with PE in the primary care setting of a large community-based health system fared. The researchers found a very low incidence of 7-day PE related hospitalization and a low rate of 30-day serious adverse events among the adult patients who were not transferred to the emergency department or hospital. Also, in August 2022, a panel reviewed the American Society of Hematology (ASH)'s guidelines on managing deep vein thrombosis (DVT) and PE and suggested that home treatment is a possible option. The ASH Clinical Practice Guidelines on Venous Thromboembolism (VTE) stated, 'The panel also made conditional recommendations expressing a preference for home treatment over hospital-based treatment of uncomplicated cases of DVT and PE. Home treatment is suggested when there is a low risk for complications as well as a preference for direct oral anticoagulants for primary treatment of VTE.' One major component of this option, however, is making sure that a patient is actually at low risk. In fact, the authors of the Journal of General Internal Medicine study also noted that the patients diagnosed with PE in primary care tended to be at low risk, and making that determination is crucial. Typically, physicians who suspect PE begin with a physical examination of the patient. While the physician's clinical gestalt is important, many also use clinical probability scoring systems such as the Wells criteria to assess factors such as a patient's immobility, clinical symptoms of DVT, a previous DVT or PE, and hemoptysis, or the Geneva scoring system. The diagnosis of PE requires imaging studies such as computed tomographic pulmonary angiography, and lab tests, notably the D-dimer test, to confirm the likelihood of a PE. The next step is determining if the patient is at low, intermediate, or high risk. That information is crucial to making a decision about how to proceed, whether it's initiating anticoagulation treatment on an outpatient basis and sending the patient home, or it's directing the patient to go directly to the emergency department. Pulmonologist Gustavo Heresi, MD, Cleveland Clinic, Cleveland, emphasized the importance of risk stratification to determine the likely prognosis for patients once they've been diagnosed with PE. The most commonly used prognostic tool is the Pulmonary Embolism Severity Index (PESI) index, which predicts 30-day mortality in patients with PE, and its simplified version, the sPESI, which uses fewer criteria but produces comparable accuracy results. Physicians can also use the Hestia criteria, Heresi said. Gustavo Heresi, MD If a physician determines that a patient is at low risk, then it can be appropriate for a PCP to manage the patient's condition. 'The initial management can be done in the primary care setting,' said Sai Sunkara, MD, a pulmonologist with UI Health in Chicago. In fact, it's easier now than in the past, given the advances in anticoagulation therapy, such as the use of direct oral anticoagulants. 'Low-risk patients who are stable and minimally at risk, can be treated at home after getting their diagnosis and a treatment plan,' agreed Heresi. But he cautioned that he can't envision the normalization of treating intermediate- or higher-risk patients in a nonemergent setting. 'I don't think that's likely to be conducive to an outpatient treatment management plan,' he said. Even for low-risk patients, there may be some barriers to outpatient management. According to Geoff Chupp, MD, professor of medicine (pulmonary, critical care, and sleep medicine) at the Yale School of Medicine, New Haven, Connecticut, not every primary care office may have the necessary diagnostic equipment, such as CT machines. What PCPs Already Do PCPs already play a key role in caring for patients affected by PE. For example, they may educate patients at elevated risk for DVT because DVT can lead to a PE. Risk factors include cancer, a history of prior thromboembolism, pregnancy, and certain medical conditions, as well as people who have recently undergone surgery or spent time immobilized 'That's generally what we try to do is educate people,' said Lori Solomon, MD, MPH, a family physician and director of the Family Health Center at New York Medical College in Valhalla, New York. 'But sometimes you don't expect people to come in with pulmonary embolisms, so sometimes you just have to be vigilant when people come in and listen to their symptoms and take them seriously.' Lori Solomon, MD, MPH Even if the PCP does not take on the initial treatment of a PE, they still play a key role later. Around the 3-month mark, some patients become less adherent with treatment, said Branden Turner, MD, a family medicine physician with Kaiser Permanente in Los Angeles. 'It's just human nature,' he said. 'The initial fear is gone, but you still need to take your medications.' He sets up telephone appointments at regular intervals to check in with patients. However, some patients may not realize when they can discontinue their anticoagulation therapy, and PCPs can take on that role, too, said Solomon. 'It's easy to start a medication, but sometimes people forget to stop it,' she said. Prioritizing Social Determinants of Health Before a physician contemplates sending a low-risk patient home on anticoagulant therapy, they need to find out some key pieces of information. For example, Wilson Pace, MD, professor emeritus in family medicine, Anschutz Medical Campus of the University of Colorado, Aurora, Colorado, suggested determining: What is the patient's living situation? Do they have someone at home who can help them, or do they live alone? Is it possible to arrange for a home health nurse to check in on the patient at home? Does the patient have a pulse oximeter and blood pressure monitor to use at home? Branden Turner, MD PCPs are already well positioned to have or gather this type of information, said Solomon. 'That is why having a PCP is so important,' she added. 'Treatment plans and follow-up are very dependent on a patient's support system and living conditions.' Turner agreed. 'This is the crux to me of a good primary care physician: Being able to personalize the care to the patient based on the individual to get the best outcome for them,' he said. 'Health equity in practice. As long as the plan works for the patient and is safe, I'm open to navigate how to achieve the goal.'
Associated Press
15-05-2025
- Business
- Associated Press
Aptevo Therapeutics Reports 1Q25 Financial Results And Provides an Update on Mipletamig
9 of 10 frontline AML patients achieve remission with mipletamig + standard of care across two trials Mipletamig triplet combination continues to outperform standard doublet benchmark No cytokine release syndrome observed in the ongoing RAINIER trial: favorable safety profile supports role in frontline AML Cohort 2 enrollment is complete, and Cohort 3 is now enrolling Aptevo Therapeutics Inc. (Nasdaq:APVO), a clinical-stage biotechnology Company focused on developing novel immune-oncology therapeutics based on its proprietary ADAPTIR® and ADAPTIR-FLEX® platform technologies, today reported financial results for the quarter ended March 31, 2025, and provided an update on the ongoing mipletamig clinical trial. Business Update 'The latest outcomes from the RAINIER trial-remissions that were achieved rapidly and with no reported cytokine release syndrome-underscore the strength of our approach and the potential of mipletamig to redefine frontline AML treatment. With each milestone, we are not only validating the safety and efficacy of our drug, but moving closer to changing the standard of care for patients who have long had limited options. We remain focused on advancing the trial and look forward to sharing further clinical updates in the months ahead. This is more than progress-it's momentum toward a new era in frontline AML care,' said Marvin White, President and CEO of Aptevo. Mipletamig Data Highlights Enrollment continues in the RAINIER dose optimization trial. This is a Phase 1b/2 study evaluating mipletamig in combination with venetoclax and azacitidine, the standard of care for frontline acute myeloid leukemia (AML) patients who are unfit to receive intensive high dose chemotherapy. Cohort 2 enrollment is now complete, and Cohort 3 is now open and enrolling. Mipletamig has been evaluated in almost 100 patients across three clinical studies, thus far, in both combination and monotherapy settings. Outcomes have consistently demonstrated a growing body of evidence that supports its potential role in the treatment of frontline AML. Data Highlights include: Efficacy Results Reported on March 20, 2025 Safety Mipletamig continues to demonstrate a highly favorable safety profile, particularly with respect to cytokine release syndrome (CRS)-a common and often dose-limiting side effect seen in other T-cell engagers and bispecific antibodies. Additional Data *Remission = complete remission (CR) and, complete remission with blood markers that have not yet recovered CRi. The Company anticipates providing multiple data readouts in 2025 and to present results at the American Society of Hematology meeting in the fourth quarter. About Mipletamig Mipletamig, a differentiated by design CD123xCD3 bispecific antibody built on Aptevo's ADAPTIR platform and driven by a unique CRIS-7-derived CD3 binding domain, is being investigated as frontline therapy in combination with venetoclax and azacitidine, the current standard of care for AML patients who are unfit for intensive chemotherapy. These latest results further reinforce mipletamig's potential as a transformative treatment, supported by impressive efficacy, safety, and tolerability data from two prior clinical trials involving almost 100 patients. 2025 Summary Financial Results Cash Position: Aptevo had cash and cash equivalents as of March 31, 2025, totaling $2.1 million. This excludes approximately $4.9 million raised by the Company in April and May 2025 through direct offerings and use of the Company's ATM facility. Research and Development Expenses: Research and development expenses decreased by $0.2 million, from $3.8 million for the three months ended March 31, 2024, to $3.6 million for the three months ended March 31, 2025. The decrease was primarily due to lower preclinical and spending due to escalation phase ramping down and was offset by higher mipletamig trial costs from clinical trial patient enrollment. General and Administrative Expenses: General and administrative expenses decreased by $0.6 million, from $3.2 million for the three months ended March 31, 2024, to $2.6 million for the three months ended March 31, 2025. The decrease is primarily due to lower stock-based compensation costs. Other Income, Net: Other income, net consists primarily of interest income from our cash equivalents and short-term rental income. Other income, net was $0.1 million for the three months ended March 31, 2025, and 2024. Net Income (Loss): Aptevo had a net loss of $6.3 million or $4.35 per share for the three months ended March 31, 2025, compared to a net loss of $6.8 million or $368.21 per share for the corresponding period in 2024. Aptevo Therapeutics Inc. CONSOLIDATED BALANCE SHEETS (in thousands, except share and per share amounts) Aptevo Therapeutics Inc. CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share amounts) About Aptevo Therapeutics Aptevo Therapeutics Inc. (Nasdaq: APVO) is a clinical-stage biotechnology Company focused on developing novel bispecific immunotherapies for the treatment of cancer. The Company has two clinical candidates. Mipletamig is currently being evaluated in RAINIER, a two-part Phase 1b/2 trial for the treatment of frontline acute myeloid leukemia in combination with standard-of-care venetoclax + azacitidine. Mipletamig has received orphan drug designation ('orphan status') for AML according to the Orphan Drug Act. a bispecific conditional 4-1BB agonist, only active upon simultaneous binding to 4-1BB and 5T4, is being co-developed with Alligator Bioscience and is being evaluated in a Phase 1 clinical trial for the treatment of multiple solid tumor types likely to express 5T4. The Company has three pre-clinical candidates with different mechanisms of action designed to target a range of solid tumors. All pipeline candidates were created from two proprietary platforms, ADAPTIRand ADAPTIR-FLEX. The Aptevo mission is to improve treatment outcomes and transform the lives of cancer patients. For more information, please visit Safe Harbor Statement This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, without limitation, Aptevo's expectations about the activity, efficacy, safety, tolerability and durability of its therapeutic candidates and potential use of any such candidates, including in combination with other drugs, as therapeutics for treatment of disease, its expectations regarding the effectiveness of its ADAPTIR and ADAPTIR-FLEX platforms, statements related to the progress of Aptevo's clinical programs, including statements related to anticipated clinical and regulatory milestones, whether further study of mipletamig in a Phase 1b dose optimization trial focusing on multiple doses of mipletamig in combination with venetoclax + azacitidine on a targeted patient population will continue to show remissions, whether Aptevo's final trial results will vary from its earlier assessment, whether Aptevo's strategy will translate into an improved overall survival in AML, especially among patient subgroups with poor prognosis, whether further study of across multiple tumor types will continue to show clinical benefit, the possibility and timing of interim data readouts for statements related to Aptevo's cash position and balance sheet, statements related to Aptevo's ability to generate stockholder value, whether Aptevo will continue to have momentum in its business in the future, and any other statements containing the words 'may,' 'continue to,' 'believes,' 'knows,' 'expects,' 'optimism,' 'potential,' 'designed,' 'promising,' 'plans,' 'will' and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on Aptevo's current intentions, beliefs, and expectations regarding future events. Aptevo cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Aptevo's expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. There are several important factors that could cause Aptevo's actual results to differ materially from those indicated by such forward-looking statements, including a deterioration in Aptevo's business or prospects; further assessment of preliminary or interim data or different results from later clinical trials; adverse events and unanticipated problems, adverse developments in clinical development, including unexpected safety issues observed during a clinical trial; and changes in regulatory, social, macroeconomic and political conditions. For instance, actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the uncertainties inherent in the results of preliminary or interim data and preclinical studies being predictive of the results of later-stage clinical trials, initiation, enrollment and maintenance of patients, and the completion of clinical trials, the availability and timing of data from ongoing clinical trials, the trial design includes combination therapies that may make it difficult to accurately ascertain the benefits of mipletamig, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners or raise funds on acceptable terms or at all and other matters that could affect the availability or commercial potential of Aptevo's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the coronavirus (referred to as COVID-19), geopolitical risks, including the current war between Russia and Ukraine and the war between Israel and Hamas, and macroeconomic conditions such as economic uncertainty, rising inflation and interest rates, continued market volatility and decreased consumer confidence. These risks are not exhaustive, Aptevo faces known and unknown risks. Additional risks and factors that may affect results are set forth in Aptevo's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and its subsequent reports on Form 10-Q and current reports on Form 8-K. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Aptevo's expectations in any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Aptevo does not assume any obligation to update any forward-looking statement to reflect new information, events, or circumstances. CONTACT: Miriam Weber Miller Head, Investor Relations & Corporate Communications Aptevo Therapeutics Email: [email protected] or [email protected] Phone: 206-859-6628 SOURCE: Aptevo Therapeutics press release
