News (Proprietary)
Biomarkers Currently Tested in Metastatic NSCLC | Targeted Oncology - Immunotherapy, Biomarkers, and Cancer Pathways
4+ day, 3+ hour ago (142+ words) While this panel has grown in recent years, many experts believe additional biomarkers should also be incorporated as emerging data support targeted options in earlier disease settings. Expanding ... In early-stage NSCLC, biomarker testing typically focuses on EGFR mutations, ALK rearrangements, and PD-L1 expression, largely to guide decisions around adjuvant targeted therapy or immunotherapy While this panel has grown in recent years, many experts believe additional biomarkers should also be incorporated as emerging data support targeted options in earlier disease settings Expanding biomarker testing in early-stage NSCLC ensures that high-risk patients are identified sooner and may benefit from precision therapies that could reduce recurrence risk and improve long-term survival Broader testing also helps align early-stage treatment strategies with the advances seen in metastatic disease, paving the way for more individualized and potentially more effective perioperative treatment plans....
Patient Survey Sheds Light on Critical Communication Gaps in NMIBC Care | Targeted Oncology - Immunotherapy, Biomarkers, and Cancer Pathways
1+ week, 1+ day ago (340+ words) A recent survey revealed that patients with non'muscle invasive bladder cancer (NMIBC) in the US seek more comprehensive care conversations, calling for more open patient-provider dialogue about available treatment options.1 The survey, conducted online by The Harris Poll on behalf of ImmunityBio among 200 adult patients in the US between September and October 2025, offers compelling insights into patients" perspectives of NMIBC treatment and their personal experiences amid a rapidly evolving treatment landscape. "This survey highlights the urgent need for patients and providers to engage in deeper, more collaborative conversations about all treatment choices for [NMIBC]," said Richard Adcock, president and CEO of ImmunityBio, in a news release.1 Other overarching treatment priorities identified by patients include quick effectiveness in stopping or slowing disease progression and lasting duration of such positive treatment effects. "Immunotherapy is empowering the body"s own defenses to fight…...
Dr Hinrichs on the Future of Cell Therapy Access: From Cancer Centers to Communities | Targeted Oncology - Immunotherapy, Biomarkers, and Cancer Pathways
1+ week, 1+ day ago (208+ words) Dr. Christian S. Hinrichs discusses the future of specialized cell therapies, predicting broader access for community clinics similar to CAR T cell treatments. In an interview with Targeted Oncology, Christian S. Hinrichs, MD, co-director of the Cancer Immunology and Metabolism Center of Excellence at Rutgers Cancer Institute, offers his thoughts on the future of specialized cell therapies such as autologous tumor-infiltration lymphocyte (TIL) cell therapy and engineered T cell receptor (TCR)-T cells, particularly in the community clinic setting. Watch part 1, part 2, and part 3 of Dr Hinrichs" interview. However, Dr Hinrichs suggests that the distribution model of the therapies currently in development would likely mirror that of current CAR T-cell approaches. The observation is that CAR T-cell treatments are already "starting to move more toward community centers," suggesting that efforts are underway to offer this type of treatment more broadly and safely....
Why Early Action Matters: Referrals and Screenings for Novel Cell Therapies | Targeted Oncology - Immunotherapy, Biomarkers, and Cancer Pathways
1+ week, 4+ hour ago (177+ words) Dr. Hinrichs emphasizes the critical need for early referrals and screenings for patients considering advanced cell therapies, enhancing treatment outcomes. Watch part 1 and part 2 of Dr Hinrichs" interview. He also shares his personal perspective regarding the clinical rationale for moving these treatments earlier in the disease course, as treatments generally tend to perform better in earlier lines of therapy. "It's somewhat remarkable that we've seen results as good as they are in our phase 2 trial [NCT05686226] in what is essentially or approaching a last line setting," Dr Hinrichs notes in the interview. Since these specialized treatments are designed as one-interventions, the field must strive to take these opportunities before the patient has exhausted all possibilities and before their performance status weakens, which affects their ability to safely participate and achieve a good result. To reduce the logistical burden of navigating complex…...
Combined Therapy Shows Promising 70% Response Rate in NET Trials | Targeted Oncology - Immunotherapy, Biomarkers, and Cancer Pathways
3+ week, 2+ day ago (251+ words) A novel treatment combining chemotherapy and PRRT shows promising safety and efficacy for neuroendocrine tumors, with high response rates and ongoing trials. Michael Soulen, MD, spoke to Targeted Oncology about the safety and efficacy regarding the novel combined treatment for neuroendocrine tumors (NETs) that utilizes both systemic chemotherapy and peptide receptor radionuclide therapy (PRRT), specifically Lutetium-177 dotatate, at the 2025 North American Neuroendocrine Tumor Society (NANETS) Symposium. Soulen described a 21-patient phase 1 study successfully conducted several years ago to assess the combination's tolerability. The primary concern was potential synergistic toxicity, which could render the treatment intolerable for patients. However, the study demonstrated that the combined approach was feasible and safe, provided the treatment cycle was slightly adjusted from the initial 28-day model. The key adjustment was extending the interval between treatments to allow for proper bone marrow recovery. Regarding efficacy, the…...
43rd Annual Chemotherapy Foundation Symposium: The Show and After Show | Targeted Oncology - Immunotherapy, Biomarkers, and Cancer Pathways
2+ week, 5+ day ago (369+ words) Join the 43rd Annual Chemotherapy Foundation Symposium in New York City for cutting-edge cancer care education and networking opportunities. Welcome to The Show and After-Show with Andrew Svonavec and Kristie L. Kahl, your essential guide to the 43rd Annual Chemotherapy Foundation Symposium (CFS). This must-attend event, with a genesis dating back to the 1980s, has long set the standard for cancer care education. CFS 2025 takes place from November 12-14 , calling the New York Hilton Midtown home once again. Co-chaired by Benjamin P. Levy, MD; John O. Mascarenhas, MD; and Tiffany A. Traina, MD, FASCO, the program is designed around 4 critical learning objectives: " Evaluating efficacy and safety data from recent pivotal trials. " Applying strategies to identify and mitigate treatment-related adverse effects to improve quality of life. On day 1, focused on hematology, the program is packed for specialists, including sessions on multiple myeloma (MM) and leukemia. Noa Biran, MD, will discuss…...
Novel TROP2-Targeting ADC Gains FDA Orphan Drug Status in Cholangiocarcinoma | Targeted Oncology - Immunotherapy, Biomarkers, and Cancer Pathways
1+ week, 2+ day ago (471+ words) OBI-902, targeting TROP2, gains FDA orphan drug status for cholangiocarcinoma, a rare cancer with poor prognosis and limited treatments. Orphan drug designation provides benefits like tax credits and ... OBI-902, a novel TROP2-targeting antibody-drug conjugate (ADC), has been awarded FDA orphan drug designation in cholangiocarcinoma.1 Orphan drug status is awarded to novel agents intended to prevent, diagnose, or treat rare diseases or conditions.2 Cholangiocarcinoma, a set of rare malignancies in the biliary tract, accounts for only 3% of gastrointestinal cancers and carries a 5-year survival rate of 20% or less, necessitating development of novel therapeutics to overcome the disease's lack of approved treatments and poor prognosis.3 With sponsors of designated drugs qualifying for user fee exemptions, tax credits for clinical trials, and a potential 7 years of market exclusivity after approval, this designation marks another promising step forward in OBI-902's development pathway following the…...
FDA Accepts NDA for Zidesamtinib in Advanced ROS1+ NSCLC | Targeted Oncology - Immunotherapy, Biomarkers, and Cancer Pathways
1+ week, 2+ day ago (373+ words) The FDA reviews zidesamtinib for advanced ROS1+ NSCLC, promising new treatment options for patients resistant to current therapies. The FDA has accepted the new drug application (NDA) for zidesamtinib (NVL-520), an investigational ROS1-selective inhibitor.1 Under the Prescription Drug User Fee Act, the FDA has set a target action date of September 18, 2026. "Continued innovation for patients with [ROS1+] NSCLC is needed. Limitations of currently available ROS1 TKIs can lead to trade-offs between efficacy and tolerability in the front-line, and there is no clear targeted therapy care standard for TKI-pretreated patients," said'Alexander Drilon, MD, chief, Early Drug Development Service at Memorial Sloan Kettering Cancer Center, in a news release.3 Submission was based on positive data from the ongoing phase 1/2 ARROS-1 trial (NCT05118789) presented in September 2025 at the IASLC World Conference on Lung Cancer (WCLC), which showed promising, durable responses and tolerable safety.4 Among 117 TKI-pretreated, ROS1+ patients with…...
Dr Benjamin George: Cancer Care Is “Done as a Team” | Targeted Oncology - Immunotherapy, Biomarkers, and Cancer Pathways
4+ day, 21+ hour ago (328+ words) Dr Benjamin George champions patient-centered oncology in rural Nebraska, enhancing local cancer care access and fostering community support for patients. We're proud to introduce Benjamin George, MD, as our second 2025 Oncology Icon. With more than 20 years of experience, including 11 years of service in the US Army, George brings a deep commitment to patient-centered cancer care, especially in serving his rural community as the medical director of oncology at Community Hospital in McCook, Nebraska. George was nominated by peers and selected from a pool of nominees by the editorial boards of Targeted Therapies in Oncology and Peers and Perspectives in Oncology. In an interview with Targeted Oncology, George discusses his background, journey to oncology, and commitment to serving rural communities. Targeted Oncology: What led you to wanting to work in oncology? Also, we've had tremendous growth [in the science and understanding…...
October 2025: A Look at FDA Oncology Approvals and Designations | Targeted Oncology - Immunotherapy, Biomarkers, and Cancer Pathways
4+ week, 13+ hour ago (859+ words) October 2025 marked a pivotal month in oncology with multiple FDA approvals and designations, enhancing treatment options for various cancers. October 2025 proved to be a significant month for the oncology landscape, marked by a wave of key regulatory decisions from the FDA. This period saw important full and accelerated drug approvals across various cancer types, expanding treatment options for patients with both solid tumors and hematologic malignancies. From new combination maintenance therapies for extensive-stage small cell lung cancer (ES-SCLC) and an adjuvant treatment for high-risk cutaneous squamous cell carcinoma (CSCC), to a crucial approval in relapsed or refractory acute myeloid leukemia (AML) with a specific mutation, the month delivered on several anticipated action dates. Furthermore, the FDA continued to expedite the development of promising agents by granting several breakthrough therapy and fast track designations, signaling a robust pipeline of innovative oncology…...