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T-DM1 was found to be tolerable, but progression-free survival was not improved vs historical data in HER2-positive biliary tract cancer. 

T-DM1 Is Not Associated With Improved PFS vs Historical Controls in Pretreated HER2+ Biliary Tract Cancer

Overall survival data were linked with baseline geriatric assessment and QOL scores in patients with metastatic pancreatic ductal adenocarcinoma.

OS With Chemotherapy Is Linked With Baseline Geriatric, QOL Factors in Metastatic Pancreatic Cancer

The combination of bezuclastinib and sunitinib generated favorable efficacy outcomes vs historical data in patients with previously treated GIST.

Bezuclastinib Plus Sunitinib Elicits Preliminary Activity, Is Safe in Pretreated GIST

Detectable ctDNA after neoadjuvant chemotherapy was associated with the  recommendation for TME in patients with T1-3, N0 low or mid rectal cancer.

Post-Chemotherapy ctDNA Status May Support Organ Preservation Decisions in Rectal Cancer

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 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

A final analysis of the LIGHT trial showed olaparib demonstrated higher OS rates in patients with relapsed ovarian cancer who had germline or somatic BRCA mutations. 

Olaparib Elicits Improved OS Rates in Platinum-Sensitive, Germline/Somatic BRCA+ Relapsed Ovarian Cancer

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

Megan Hollasch joined MJH Life Sciences in 2022 following graduation from the University of Massachusetts Amherst with majors in Communication and English, and a specialization in Literature as History. She produces and edits original content for the print publication 

, aiding in all aspects of the publication process, as well as content for OncLive.com.

CAR T-cell therapies are associated with a risk for second primary cancers, and mitigation strategies for these toxic effects are warranted and under examination.

Second Primary Cancer Risk Informs the Risk-Benefit Profile of CAR T-Cell Therapies

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.

Marcia Cruz-Correa, MD, PhD, AGAF, FASGE, discusses the FDA approval of tislelizumab with chemotherapy for advanced gastric or GEJ adenocarcinoma.

FDA Approval of Tislelizumab Plus Chemo Offers a New Option in Advanced Gastric/GEJ Adenocarcinoma

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Joshua Hurwitz discusses findings from a study investigating the safety of adding multifocal MRI-directed simultaneous integrated boost to stereotactic body radiation therapy in patients with prostate cancer.

Hurwitz on the Safety Profile of Simultaneous Integrated Boost Plus SBRT in Prostate Cancer

Brief Overview of Synovial Sarcoma: What It Is, Clinical Presentation and Diagnosis

Video content above is prompted by the following:

What is synovial sarcoma, and how does it differ from other types of soft-tissue sarcomas?

 fusion oncogene define this rare malignancy?

Panelists discuss how synovial sarcoma is a rare soft-tissue cancer characterized by its unique SS18::SSX fusion oncogene transcript, which distinguishes it from other sarcomas and drives its aggressive behavior through altered epigenetic regulation, despite its misleading name suggesting origin in synovial tissue. 

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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.

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.

Joshua Hurwitz

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