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PALOMA-2 Study Confirms Efficacy of Subcutaneous Amivantamab in EGFR Exon 20 Insertion NSCLC

Targeted TherapyDrug Approval
  • The phase 2 PALOMA-2 study demonstrated that subcutaneous amivantamab plus chemotherapy achieved a 76% objective response rate in patients with EGFR exon 20 insertion-mutated advanced NSCLC.
  • Results showed consistency with the pivotal PAPILLON study, with a clinical benefit rate of 94% and median progression-free survival of 12.2 months at 10-month follow-up.
  • The subcutaneous formulation offers enhanced tolerability and convenience without sacrificing efficacy compared to intravenous administration.
  • European Commission approval in April 2025 for subcutaneous amivantamab formulations is expected to expand clinical applicability and lead to additional regulatory approvals.

A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

NCT04487080Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 9/30/2020

A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions

NCT04538664Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 10/13/2020

A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer

NCT05388669Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 8/5/2022

A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer

NCT05498428RecruitingPhase 2
Janssen Research & Development, LLC
Posted 11/11/2022

MIT Researchers Develop Bottlebrush Polymer Technology to Dramatically Increase Cancer Drug Payload Delivery

Targeted Therapy
  • MIT chemists have developed antibody-bottlebrush conjugates (ABCs) that can deliver hundreds of drug molecules per antibody, compared to the maximum of eight in current FDA-approved ADCs.
  • The bottlebrush particles successfully eliminated most tumors in mouse models of breast and ovarian cancer using doses 100 times lower than traditional chemotherapy.
  • This technology enables the use of less potent drugs like doxorubicin and paclitaxel, expanding treatment options beyond the highly toxic agents required by current ADCs.
  • The modular design allows for combination therapies and can be adapted to target different cancer types by swapping antibodies targeting proteins like HER2 and MUC1.

Cambridge Scientists Develop pH-Responsive Artificial Cartilage for Targeted Arthritis Drug Delivery

Targeted Therapy
  • University of Cambridge researchers have engineered artificial cartilage that automatically releases anti-inflammatory drugs in response to the acidic conditions present during arthritis flare-ups.
  • The smart material becomes softer and more jelly-like as joint acidity increases, triggering precise drug release only within a narrow pH range to minimize side effects.
  • Laboratory tests demonstrated substantially higher drug release at acidity levels typical of arthritic joints compared to normal, healthy pH levels.
  • The versatile approach could potentially treat arthritis continuously for days, weeks, or months while reducing the £10.2 billion annual NHS cost burden of arthritis care.

Four JAK Inhibitors Now Enable Personalized Myelofibrosis Treatment Approaches

Targeted Therapy
  • The myelofibrosis treatment landscape has evolved from a single JAK inhibitor to four FDA-approved options, enabling more personalized therapeutic approaches based on patient-specific clinical presentations.
  • Ruxolitinib remains the gold standard with proven survival benefits but requires appropriate dosing of at least 15 mg twice daily to achieve optimal efficacy.
  • Newer JAK inhibitors address specific clinical challenges: momelotinib for anemia-predominant disease, pacritinib for severe thrombocytopenia, and fedratinib as a second-line option for patients with preserved blood counts.
  • Treatment selection now focuses on tailoring therapy to individual patient presentations, including cytopenia profiles, symptom burden, and disease progression status.

Adjuvant Crizotinib Fails to Improve Disease-Free Survival in Early-Stage ALK-Positive NSCLC

Targeted Therapy
  • The Phase 3 E4512 ALCHEMIST trial demonstrated that adjuvant crizotinib did not improve disease-free survival compared to observation in patients with resected early-stage ALK-positive NSCLC.
  • After a median follow-up of 58.3 months, crizotinib showed a hazard ratio of 1.06 for disease-free survival with no statistical significance, while overall survival data remain immature.
  • Treatment discontinuation occurred in 25% of patients due to adverse effects, with grade 3 or higher toxicities affecting 43% of crizotinib-treated patients.
  • The findings support the current standard of care using second-generation ALK inhibitors like alectinib for adjuvant therapy in this patient population.

Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial)

NCT02194738Active, Not RecruitingNot Applicable
National Cancer Institute (NCI)
Posted 9/26/2014

Nuvation Bio Surges 14.9% on Analyst Upgrades and Oncology Pipeline Progress

OncologyTargeted Therapy
  • Nuvation Bio Inc. stock surged 14.9% driven by promising clinical trial results and positive analyst sentiment from major investment firms.
  • Wedbush raised its price target to $6 while RBC increased its target to $7, reflecting growing confidence in the company's diverse oncology pipeline.
  • The company's strategic focus includes next-generation treatments such as a ROS1 inhibitor and brain-penetrant IDH1 inhibitor for cancer therapy.
  • Despite current profitability challenges with significant net losses, strong liquidity position and increased investor conference participation signal potential growth trajectory.

HUTCHMED Presents Clinical Data for Multiple Cancer Therapies at Major Oncology Conferences

Targeted TherapyOncology
  • HUTCHMED will present updated clinical data for savolitinib, a selective MET tyrosine kinase inhibitor, at the 2025 World Conference on Lung Cancer, including results from SACHI, SAVANNAH, and Phase IIIb studies in non-small cell lung cancer patients.
  • The company will showcase first-in-human Phase I data for HMPL-653, a novel CSF-1R inhibitor for tenosynovial giant cell tumor, at the Chinese Society of Clinical Oncology Annual Meeting 2025.
  • Multiple investigator-initiated studies will be presented featuring fruquintinib and surufatinib combination therapies across various cancer types including colorectal, pancreatic, and biliary tract cancers.
  • The presentations span two major conferences from September 6-14, 2025, highlighting HUTCHMED's diverse oncology pipeline and collaborative research efforts.

Sugar-Coated Nanoparticles Show Promise for Triple-Negative Breast Cancer Treatment

Targeted Therapy
  • University of Mississippi researchers developed sugar-coated nanoparticles that exploit cancer cells' glucose transporter overexpression to deliver chemotherapy drugs more effectively to triple-negative breast cancer.
  • The innovative approach could reduce side effects by selectively targeting cancer cells while sparing healthy tissue, addressing a critical need for this aggressive cancer subtype.
  • Mississippi shows particularly high rates of triple-negative breast cancer, with 37% of breast cancer patients treated at the University of Mississippi Medical Center between 2016-2023 having this subtype.
  • The delivery mechanism may have broader applications for other diseases that overexpress glucose transporters, including colon cancer, brain cancer, and fatty liver disease.

Black Diamond Therapeutics Completes Enrollment in Phase II Study of EGFR Inhibitor Silevertinib for NSCLC

OncologyTargeted Therapy
  • Black Diamond Therapeutics has completed enrollment in its mid-stage study of silevertinib, a fourth-generation EGFR inhibitor targeting non-classical EGFR mutations in frontline NSCLC patients.
  • The company plans to disclose objective response rate and duration of response data from all 43 patients in Q4 2025, with FDA feedback on a potential registrational path expected in H1 2026.
  • Silevertinib faces significant competition in the NSCLC space, particularly from Johnson & Johnson's recently approved Rybrevant plus Lazcluze combination and AstraZeneca's established Tagrisso therapy.
  • Following the outlicensing of BDTX-4933 to Servier Pharmaceuticals, Black Diamond is now solely focused on silevertinib development and actively seeking strategic partners for advancement.

Perspective Therapeutics Names Joel Sendek as CFO to Advance Alpha Radiopharmaceutical Programs

Targeted Therapy
  • Perspective Therapeutics appointed biotech veteran Joel Sendek as Chief Financial Officer, bringing extensive experience from four previous CFO roles and over $2.5 billion in fundraising expertise.
  • Sendek joins as the radiopharmaceutical company advances three clinical programs using proprietary 212Pb alpha-emitting isotope technology for targeted cancer treatment.
  • The appointment comes during ongoing Phase 1/2a trials for neuroendocrine tumors, melanoma, and solid tumors, positioning the company to establish leadership in targeted alpha radiopharmaceutical therapy.

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