hPAM4-Cide (yttrium Y-90 clivatuzumab tetraxetan) / Gilead - LARVOL DELTA

Clinical Cases in Hepatocellular Carcinoma - Episode 12: Future Treatment Approaches for HCC (Targeted Oncology) - "Aparna Kalyan, MD: You're right. The future is going to be, how are all these combination therapies going to come into play? As we bring the session to a conclusion, my thought to both of you would be what do you think the future looks like? I personally feel like there's going to be a struggle in terms of what I do in the second line, particularly if there are combinations that come out, because I don't know how to look at that space. I'm curious to know, Dr Kim, what do you think from an interventional radiology perspective, and then maybe Dr George, from a medical oncology perspective?"

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Clinical Cases in Hepatocellular Carcinoma - Episode 9: Defining the Role of Adjuvant Therapy for HCC (Targeted Oncology) - "Aparna Kalyan, MD: I'm curious to know, I've seen a few more of these cases recently. The space of adjuvant therapy is unknown, we've had a lot of missed hits in that space for multiple reasons. Dr Kim, I'm curious, we see this a lot. I have a patient who has a Child-Pugh A score, has a large lesion, around 4 or 5 cm, for other reasons not necessarily related to the tumor is not a surgical or a transplant candidate, and we treat them with Y-90 [yttrium-90 radioembolization], which is the standard in this space. Are there situations where your team discusses adjuvant therapy for those patients? I know there are trials ongoing, but I'm just curious to know how you approach it."

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Dr. Mulcahy on Key Takeaways from the EPOCH Trial With TheraSphere Y-90 in CRC (OncLive) - "Mary F. Mulcahy, MD...discusses the key takeaways from the ongoing EPOCH trial (NCT01483027) in patients with colorectal cancer (CRC) and liver metastases. Multiple prespecified subgroups were investigated on the study to determine which patients would benefit most from the addition of TheraSphere™ Yttrium-90 (Y-90) Glass Microspheres to systemic therapy, according to Mulcahy. Y-90 resulted in promising responses in patients whose tumors harbored KRAS mutations....however, only 40% of patients who had KRAS wild-type disease received a biologic agent with their second line of treatment, Mulcahy notes. It is possible that if more patients received a biologic agent, there would have been even better outcomes, Mulcahy concludes."

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Radioembolization With Chemotherapy for Colorectal Liver Metastases: A Randomized, Open-Label, International, Multicenter, Phase III Trial (OncLive) - "Expert Riad Salem, MD, MBA, highlights key data from the phase 3 EPOCH study, which evaluated TheraSphere in patients with mCRC and liver metastases who failed first line chemotherapy."

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Radioembolisation with chemotherapy for colorectal liver metastases (YouTube) - "Dr Mary Mulcahy talks to ecancer about her study: Radioembolisation with chemotherapy for colorectal liver metastases: a randomised, open-label, international, multicenter, phase 3 trial. She begins by explaining that the liver is the most common site of metastasis for colorectal cancer and while a small percentage of those can be resected the majority cannot...Dr Mulcahy continues, once eligibility was met 428 patients from 94 centres were randomised in a 1:1 fashion to standard chemotherapy or Y-90 with chemotherapy....She concludes that they'll be evaluating all the collected data to identify patients who would be best served with the addition of Y-90 to their second-line chemotherapy....which is so important for patients with incurable metastatic disease."

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Radioembolization Plus Second-Line Chemotherapy for Colorectal Liver Metastases (THE ASCO POST) - P3, N=428; "In the phase III EPOCH trial reported in the Journal of Clinical Oncology, Mary F. Mulcahy, MD, and colleagues found that the addition of transarterial yttrium-90 radioembolization (TARE) to second-line chemotherapy significantly prolonged progression-free survival and hepatic progression–free survival in patients with colorectal liver metastases....Among the 215 patients in the TARE group, 187 (87%) received TARE, 16 received chemotherapy only, and 12 received no treatment. Among the 213 patients in the control group, 191 received chemotherapy and 22 received no therapy....The investigators concluded...Further subset analyses are needed to better define the ideal patient population that would benefit from TARE.'"

P3 data

EPOCH Trial Seeks to Establish the Role of TheraSphere Y-90 in Second-Line Metastatic CRC (OncLive) - '"With EPOCH, we sought to investigate the role of Y-90 in the second-line setting. Y-90 does not have a role in the first-line setting for metastatic CRC, and it now has a decreasing role in the salvage setting, given the competitive landscape,' study investigator Riad Salem MD, said. 'The second-line space was a prime area to see whether we could prolong progression-free survival [PFS], as well as hepatic PFS, and see whether we could either delay other types of treatments or add to standard-of-care treatment.'"

Interview

Global Real-World Data Establish TheraSphere Y-90 as Optimal Choice for HCC (OncLive) - "Principal investigator Riad Salem, MD, walked through the latest data from the TARGET study as part of an OncLive Rapid Readouts video program...The Y-90 glass microspheres are manufactured during a process in which inactive yttrium-89 is combined with aluminum and silicon into glass microspheres. After a heating process, the neutron bombardment transforms the inactive yttrium-89 trapped in the spheres into highly concentrated radioactive yttrium-90."

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Rapid Readouts: A Global Study of Advanced Dosimetry in the Treatment of HCC With Y 90 Glass Microspheres (OncLive) - "Riad Salem, MD, presents slides supporting global real-world data confirming a significant association between tumor-absorbed dose, objective response between tumor-absorbed dose and overall survival in patients with hepatocellular carcinoma (HCC) treated with yttrium-90 glass microspheres."

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Dr. Salem on Outcomes With Y-90 as Bridging Therapy Prior to Transplant in HCC (OncLive) - "Riad Salem, MD...discusses outcomes with TheraSphere Yttrium-90 (Y-90) Glass Microsphere as a bridging therapy prior to transplantation in hepatocellular carcinoma (HCC)....Investigators found that if there was more necrosis present, it was easier to kill the tumor, Salem explains. Additionally, this patient population was found to have better outcomes following transplantation. Based on this, the goal of a locoregional therapy should be to maximize tumor kill and necrosis, as this will yield the best outcomes for patients following transplantation, Salem concludes."

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FDA Approves TheraSphere Y-90 Glass Microspheres for HCC (OncLive) - '"I am honored to have spearheaded the LEGACY trial in which we found that patients with early and advanced HCC exhibited very high response rates as well as clinically meaningful durations of response and survival, establishing TheraSphere as a standard treatment for this patient population,' said lead investigator Riad Salem, MD, MBA...'The trial results, which have been accepted for publication in Hepatology, produced one of the most comprehensive databases for TheraSphere, empowering physicians to make informed, data-driven decisions for their patients.'"

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A Study of Fractionated 90Y-hPAM4 Plus Gemcitabine in Pancreatic Cancer Patients Receiving at Least 2 Prior Therapies. (clinicaltrials.gov) - P1; N=0; Withdrawn; Sponsor: Immunomedics, Inc.; N=50 ➔ 0; Active, not recruiting ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Rheumatoid Arthritis • Solid Tumor

Phase I/II study of 90Y-clivatuzumab tetraxetan (90Y-hPAM4) combined with gemcitabine (Gem) in advanced pancreatic cancer (APC): Final results (ASCO 2012) - Presentation Time: Monday June 4, 8:00 AM to 12:00 PM; P1/2, N=100; The median OS was 7.7 mo., but 11.8 mo. for retreated pts (46% (6/13) survived ≥1 yr.), and with improved efficacy at higher 90Y doses in part 1; In part 2, treatment was well tolerated with no infusion reactions; Infections requiring IV antibiotics occurred at a low rate and responded to appropriate coverage (bacteremia/sepsis, 7%; febrile neutropenia, 4%; ascending cholangitis, 3%; pneumonia, 2%; others 1%)

P1/2 data • Pancreatic Cancer

FDA puts Immunomedics cancer drug trial on hold (Reuters) - FDA has put a partial hold on the company's pancreatic cancer drug clivatuzumab tetraxetan trial after a patient was given an incorrect dose; Patient is still enrolled in the Phase 1b/2 trial, but has not received any further dose

Clinical hold • Pancreatic Cancer

Immunomedics reports favourable phase Ib/II pancreatic cancer study data (Pharmaceutical Business Review (PBR)) - P1b/2, N=100; Treatments were well tolerated with no infusion reactions to radiolabeled clivatuzumab and few non-hematologic side effects; Hematologic suppression was transient after cycles 1 and 2

P1/2 data • Pancreatic Cancer