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Tanios S. Bekaii-Saab, MD, and Yelena Y. Janjigian, MD, preview top presentations from this year’s Gastrointestinal Cancers Symposium.

Oncology Experts Preview Top Abstracts to be Shared at 2025 ASCO GI

Everolimus plus lanreotide demonstrated an improved PFS compared with everolimus monotherapy in gastroenteropancreatic neuroendocrine tumors. 

Everolimus Plus Lanreotide Extends PFS in Advanced GEP-NETs

First-line nivolumab plus chemotherapy numerically improved survival vs chemotherapy alone in Asian patients with unresectable/metastatic urothelial cancer.

Nivolumab Plus Gemcitabine/Cisplatin Shows Favorable OS/PFS Trend in Asian Unresectable/Metastatic Urothelial Cancer Subpopulation

Durvalumab plus vaccine therapy demonstrated evidence of preliminary antitumor activity without substantial additive toxicity in BCG-unresponsive NMIBC.

Durvalumab Plus Vaccine Therapy Elicits ‘Encouraging’ DFS in BCG-Unresponsive NMIBC

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Kristi Rosa joined MJH Life Sciences in 2016 and has since held several positions within the company. She helped launch the rapidly growing infectious disease news resource 

. Prior to working at the company, she served as lead copywriter and marketing coordinator at The Strand Theater. Email: krosa@onclive.com

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™. She joined the company in 2018 as an assistant editor, with expertise in video production and print/digital publication. Email: cseymour@onclive.com​ 

Jax DiEugenio joined MJH Life Sciences in 2024, first as an editorial intern before transitioning into a full-time assistant editor for 

. A recent College of New Jersey graduate, Jax majored in Journalism/ Professional Writing with minors in Public Health and Anthropology. He is also pursuing a Master's Degree in Public Health, concentrating on health communications.

 in November 2021 as a senior editor and became the website's managing editor in October 2023. Before arriving at MJH Life Sciences, he spent nearly a decade covering professional and high school sports—including the New Jersey Devils and the NHL from 2016 to 2021—for The Star-Ledger and NJ.com. Email: chryan@onclive.com

Carsten Utoft Niemann, MD, PhD, discusses improvements in toxicity-free survival with ibrutinib and venetoclax in CLL. 

Ibrutinib/Venetoclax Combo Demonstrates Sustained TEAE-Free PFS in First-Line CLL

 as an assistant editor in October 2022. Leveraging an educational background in the life sciences and prior experience conducting interviews in a university setting, she plays a key role in shaping social media strategy, covering live conferences, and producing multimedia content for both print and digital platforms. Email: 

Ashling Wahner joined MJH Life Sciences in 2022. She produces 

, and helps ensure timely publication of news content and announcements from the FDA approval pipeline. She also attends conferences live and virtually to conduct video interviews and produce written coverage. Email: awahner@mjhlifesciences.com

An additional 1-year of follow-up confirmed the safety and activity of SHR-A1811 in HER2-expressing or -mutant solid tumors, including breast cancer. 

SHR-A1811 Maintains Efficacy, Safety in Pretreated HER2-Expressing/-Mutated Breast Cancer, Other Solid Tumors

Gabriel Mannis, MD, discusses the observed clinical activity and manageable safety profile of IO-202 combined with azacitidine in CMML.

IO-202 Plus Azacitidine Could Bring Long-Awaited Change in HMA-Naive CMML 

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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Ensuring a positive patient experience should be a top priority throughout the entire treatment journey, as higher patient satisfaction can drive improved health outcomes, treatment adherence, and quality of life.

Building the Optimal Patient Experience Takes Planning and Effort

Real-world comparison of the efficacy and safety of atezolizumab versus durvalumab in extensive-stage small cell lung cancer

CORRECTION: Atezolizumab has an Overall Survival (OS) of 

Dr. Bruna Pellini presents key data comparing real-world outcomes of atezolizumab versus durvalumab in extensive-stage small cell lung cancer (ES-SCLC), demonstrating a significant overall survival advantage and lower immune-related adverse events with durvalumab, while progression-free survival remained comparable between the two treatments.

Second-line ropeginterferon alfa-2b-njft (Besremi) increased responses compared with anagrelide (Agrylin) in patients with essential thrombocythemia who were resistant or intolerant to hydroxyurea, meeting the primary end point of the phase 3 SURPASS ET trial (NCT04285086).

Findings showed that, in the intention-to-treat population, responses were observed at 9 and 12 months in 42.9% of patients administered ropeginterferon alfa-2b (n = 91) compared with 6.0% for those given anagrelide (n = 83; 

 = .0001). Responses were evaluated per modified European Leukemia Net criteria.

 V617F allelic burden decreased from 33.7% at baseline to 25.3% at 12 months in the ropeginterferon alfa-2b group vs a decrease from 39.7% to 37.3% in the anagrelide group.

Safety data showed ropeginterferon alfa-2b was manageable. Serious treatment-related adverse effects occurred in 2.2% of patients in the experimental arm vs 10% in the anagrelide arm.

“We are extremely proud of the SURPASS ET phase 3 study outcome, which shows the potential of [ropeginterferon alfa-2b] as an important new treatment option for patients with essential thrombocythemia, a rare blood cancer that drastically increases the risk of heart attack or stroke,” Ko-Chung Lin, PhD, founder and chief executive officer of PharmaEssentia, stated in a news release. “The data highlight the broad potential to apply our innovative monopegylated, long-acting interferon technology as a significant step forward for treating essential thrombocythemia, and potentially other myeloproliferative neoplasms, with non-chemotherapy treatments. We plan to leverage these data to expand the existing [ropeginterferon alfa-2b] product label and further expand the reach of [ropeginterferon alfa-2b] to address this growing global unmet medical need.”

 for the treatment of patients with polycythemia vera.

SURPASS ET was an open-label, multicenter, randomized, active-control study that enrolled patients at least 18 years of age with high-risk essential thrombocythemia per WHO 2026 criteria—defined as either being older than 60 years of age and 

 V617 positive at screening; or having a history of disease-related thrombosis or hemorrhage.

 Prior treatment with hydroxyurea was required, and patients needed to have resistance or intolerance to the agent. Adequate hematologic, hepatic, and renal function was required.

Key exclusion criteria consisted of known risk factors for QT-prolongation; comorbidities with severe or serious conditions that could affect protocol compliance, including significant cardiac disease and pulmonary hypertension; a history of major organ transplantation; and the use of any investigational drug less than 4 prior to the first study dose.

Patients were randomly assigned to receive ropeginterferon alfa-2b at 250 µg to 500 µg once every 2 weeks; or anagrelide administered per label and physician judgement.

The study’s end points were peripheral blood count remission; improvement or non-progression in disease-related signs; large symptoms improvement or maintaining non-progression; and the absence of hemorrhagic or thrombotic events. Each end point was measured at month 9 and month 12.

“The results of the SURPASS-ET trial are significant,” Albert Qin, MD, PhD, chief medical officer of PharmaEssentia, stated in a news release.

 “Essential thrombocythemia is a challenging condition associated with symptoms and risks of thrombosis and disease progression. These encouraging results highlight the potential of [ropeginterferon alfa-2b] to provide an effective and tolerable new treatment option that we believe could provide a substantial clinical benefit for patients with essential thrombocythemia. We plan to submit these results to the FDA and other regulatory agencies as soon as possible in hopes of providing this potential new treatment option to patients with essential thrombocythemia.”

: PharmaEssentia issued a revised news release on January 8, 2024, following the initial publication on January 6, 2024. This story has been updated to reflect those revisions. The revised news release is listed as the first reference.

PharmaEssentia announces positive topline phase 3 data from SURPASS-ET study evaluating ropeginterferon alfa-2b-njft (P1101) for essential thrombocythemia. News release. PharmaEssentia. January 8, 2025. Accessed January 8, 2025. https://www.biospace.com/press-releases/correcting-and-replacing-pharmaessentia-announces-positive-topline-phase-3-data-from-surpass-et-study-evaluating-ropeginterferon-alfa-2b-njft-p1101-for-essential-thrombocythemia

FDA Approves Treatment for Rare Blood Disease. FDA. November 12, 2021. Accessed January 6, 2025. https://www.fda.gov/news-events/press-announcements/fda-approves-treatment-rare-blood-disease

Ropeginterferon alfa-2b (P1101) vs. anagrelide in essential thrombocythemia patients with hydroxyurea resistance or intolerance (SURPASS ET). ClinicalTrials.gov. Updated November 30, 2023. Accessed January 6, 2025. https://clinicaltrials.gov/study/NCT04285086

Ropeginterferon alfa-2b-njft demonstrated superior efficacy over anagrelide in patients with essential thrombocythemia resistant or intolerant to hydroxyurea, achieving the primary endpoint in the phase 3 SURPASS ET trial. The study showed significant response rates at 9 and 12 months, with a notable reduction in JAK2 V617F allelic burden. Safety data indicated manageable adverse effects. The trial's success underscores the potential of ropeginterferon alfa-2b as a non-chemotherapy treatment for essential thrombocythemia, with plans to expand its use and regulatory approval.

Ropeginterferon alfa-2b improved responses in patients with essential thrombocythemia with resistance or intolerance to hydroxyurea.

Clinical

Second-Line Ropeginterferon Alfa-2b Boosts Responses in Essential Thrombocythemia

OncLive co-hosts Kristie L. Kahl and Andrew Svonavec highlight abstracts for medical oncologists to look out for at the upcoming ASH Annual Meeting.

ASH 2024 Preview for Medical Oncologists: The Show and After Show

The ASH Annual Meeting and Exposition is set to shape the future of cancer care, with a focus on chimeric antigen receptor T-cell therapies, bispecific antibodies, the role of minimal residual disease, and more.

, co-hosts Kristie L. Kahl and Andrew Svonavec offer a glimpse at some of the presentations guaranteed to spark one’s curiosity, spur debate, and enhance the field even further. Some key highlights include:

Acalabrutinib (Calquence) in mantle cell lymphoma (MCL):

 The FDA is set to review the approval of acalabrutinib with bendamustine or rituximab (Rituxan) for previously untreated MCL, based on data from the phase 3 ECHO trial (NCT02972840).

Asciminib (Scemblix) in chronic phase chronic myelogenous leukemia (CML-CP):

 The FDA recently granted accelerated approval to asciminib for newly diagnosed CML-CP. This tyrosine kinase inhibitor has shown favorable safety and tolerability profiles.

Novel Therapies for Chronic Lymphocytic Leukemia (CLL)

Acalabrutinib and venetoclax (Venclexta) combinations:

 The phase 3 AMPLIFY study (NCT03836261) and the CLL expansion and optimization cohorts of EPCORE CLL-1 (NCT04623541) are investigating the potential of novel drug combinations, including acalabrutinib and venetoclax, in the treatment of CLL. These studies may lead to new therapeutic strategies for patients with relapsed or refractory disease.

 The evaluation of epcoritamab monotherapy in relapsed or refractory CLL is generating significant excitement. This bispecific antibody targets CD20 and CD3, offering a promising approach to eliminate malignant B cells.

Advances in Acute Lymphoblastic Leukemia (ALL)

Blinatumomab (Blincyto) in pediatric ALL:

 The addition of blinatumomab to chemotherapy has shown promise in improving disease-free survival in high-risk pediatric ALL. This combination therapy may offer a more effective treatment option for young patients.

 isn't just about data, as the duo also offers food recommendations, tourist attractions and fun activities to partake in, as well as interesting facts about San Diego.

This is just a taste of the wealth of information and inspiration waiting at the 2024 ASH Annual Meeting. Check back for future meeting previews with 

OncLive co-hosts Kristie L. Kahl and Andrew Svonavec highlight abstracts for medical oncologists to look out for at the upcoming ASH Annual Meeting in San Diego, with some additional tidbits to round out the main event.

Phase 1/2 ALKOVE-1 study of NVL-655 in ALK-positive (ALK+) solid tumors

Dr. Alexander Drilon presents an update from the Phase 1/2 ALKOVE-1 study, investigating the efficacy and safety of NVL-655, a selective ALK inhibitor, in patients with ALK-positive solid tumors, highlighting durable responses in heavily pre-treated populations, including those with compound ALK resistance mutations and central nervous system involvement.

Phase 1/2 ALKOVE-1 Study of NVL-655 in ALK-positive (ALK+) Solid Tumors

Updated Efficacy and Safety From the Phase 2 PHAROS Study of Encorafenib Plus Binimetinib in Patients With BRAF V600E-Mutant Metastatic NSCLC (mNSCLC)

Dr. Martin Dietrich presents updated efficacy and safety data from the Phase 2 PHAROS study, evaluating encorafenib plus binimetinib in patients with BRAF V600E-mutant metastatic non-small cell lung cancer, showing sustained clinical activity and a consistent safety profile after extended follow-up.

Daratumumab + Bortezomib/Lenalidomide/Dexamethasone in Patients With Transplant-ineligible or Transplant-deferred Newly Diagnosed Multiple Myeloma:   Results of the Phase 3 CEPHEUS Study 

Dr. Saad Usmani discusses the results of the Phase 3 CEPHEUS study, which evaluated the combination of daratumumab with bortezomib/lenalidomide/dexamethasone (D-VRd) in transplant-ineligible or transplant-deferred patients with newly diagnosed multiple myeloma, highlighting its impact on progression-free survival and minimal residual disease negativity.

Daratumumab + Bortezomib/Lenalidomide/Dexamethasone in Patients With Transplant-ineligible or Transplant-deferred Newly Diagnosed Multiple Myeloma: Results of the Phase 3 CEPHEUS Study 

Tim Ho, PharmD, BCOP

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