Health and Pharma’s Post

In this systematic review and meta-analysis of 39 studies (85 comparisons), cancer patient participation in trials was associated with greater survival benefit compared with routine care (hazard ratio [HR], 0.76). However, survival benefit was not significantly greater when only high-quality studies were pooled (HR, 0.9) or when the sample was adjusted for possible publication bias (HR, 0.94).

Bruce Levine and Carl June weigh in on the FDA investigation into secondary T-cell cancers post CAR-T treatment. Despite the FDA probe, the experts affirm that the benefits of CAR-T therapies far outweigh potential risks in the majority of cases. The Nature Medicine Comment emphasizes the importance of continuing to offer commercial CAR-T products based on up-to-date safety information. Read the full article here: https://lnkd.in/g7cxEkAa Link to Nature Medicine Comment: https://lnkd.in/giRZ7_xz #OCBio, #OrangeCountyBio, #CGT, #CellandGeneTh

Despite significant advancements in therapeutic modalities for #hepatocellular_carcinoma (#HCC), there is still a high annual mortality rate with a rising incidence. Major challenges in #HCC clinical management are related to the development of therapy #resistance, and evasion of tumor cell apoptosis which leading unsatisfactory outcomes in HCC patients. Previous investigations have shown that #autophagy plays a crucial role in contributing to drug resistance development in #HCC. Evidence showed that #miR_29a serves as a negative regulator of #autophagy in other cancers. The current study showed that #EV20K_miR_29a treatment significantly induces cell apoptosis and reduces both cell proliferation and colony formation in HCC cell lines. In addition, the #LC3-II/LC3-I ratio was increased while the expression of key autophagy regulators #TFEB and #ATG9A were downregulated by this treatment. These findings suggest an effective blockade of #autophagy by #EV20K_miR_29a leading to #apoptosis through concomitant targeting of critical mediators within each pathway. Ref: https://lnkd.in/dQSqf4mx #HCC_Awareness_Campaign #Hepatocellular_carcinoma #Extracellular_vesicles #EV20K_miR_29a #autophagy #resistance #apoptosis #miR_29a

New screening tool could improve the survival rate of patients with hepatocellular carcinoma from 20% to 90% https://lnkd.in/dGbKD7MW Early diagnosis of hepatocellular carcinoma (HCC) -- one of the most fatal malignancies -- is crucial to improve patient survival. In a breakthrough study investigators report on the development of a serum fusion-gene machine-learning model. This important screening tool may increase the five-year survival rate of patients with HCC from 20% to 90% because of its improved accuracy in early diagnosis of HCC and monitoring the impact of treatment.

Trastuzumab deruxtecan in patients with solid tumours harbouring specific activating HER2 mutations (DESTINY-PanTumor01): an international, phase 2 study

Astellas Pharma US #Xtandi https://lnkd.in/gmQFZc-y beats Johnson & Johnson Jansen #Zytiga https://lnkd.in/gs58sph9. This study compared survival outcomes between two common #prostatecancer drugs, #abiraterone and #enzalutamide, in elderly men with advanced prostate cancer who had not yet received chemotherapy. The researchers analyzed Medicare claims data from nearly 5,500 patients. The key findings were: Patients who received abiraterone had worse overall survival compared to those who received enzalutamide. The median survival was 20.6 months for abiraterone versus 22.5 months for enzalutamide. The reduced survival with abiraterone was particularly pronounced in certain patient subgroups, including those 75 years or older, white patients, those with cardiovascular disease, diabetes, or kidney disease, and patients across different socioeconomic levels. No subgroups were identified where abiraterone provided better survival than enzalutamide. The researchers concluded that in this Medicare population of elderly men with advanced prostate cancer, abiraterone was associated with significantly shorter survival times compared to enzalutamide, especially among older patients and those with certain coexisting medical conditions. These real-world data suggest enzalutamide may be the preferred treatment option over abiraterone for this patient population.

LucidQuest Strategic Insights (lqventures.com) >>> Gene&Cell Therapy >> #JPM24: FDA's Peter Marks says some secondary cancer cases after CAR-T therapy may be 'causal,' but benefits still outweigh risks: The FDA believes that the benefit of CAR-T therapies continues to outweigh their risks amid an ongoing investigation on cases of second blood cancers developing in patients who receive the cell therapies, according to senior FDA official Peter Marks. The FDA is now investigating 22 cases of blood cancer developing after CAR-T cell therapy treatment, said Marks, the director of the FDA’s Center for Biologics Evaluation and Research, on Monday at an Alliance for Regenerative Medicine event. “Although sequencing is not available for all of them, in at least a few of the cases we know that the CAR construct is in the malignant clone, which really suggests that there was probably an association there,” Marks said. “And the onset of these was soon enough after the administration, in some cases, that it does look like there’s a causal relationship,” he continued. The FDA announced in November that it was reviewing the safety of CAR-T therapies after reports of some cancer patients developing a second blood cancer following treatment. In December, the agency added a warning label on secondary cancers to Carvykti, a CAR-T cell therapy developed by Legend Biotech and Johnson & Johnson for multiple myeloma. But as clinicians and cell therapy experts have said previously, Marks was keen to emphasize that the regulatory agency still believes the benefits of these treatments outweigh the safety risks. That includes not only approved indications in blood cancers, but clinical trials in autoimmune diseases as well, where impressive early results have jolted the field’s interest. “Where we are settling out is that, in general, the risk benefit is still going to be favorable to move forward in those development plans,” Marks said. “And that’s in part because autoimmune diseases are not benign diseases. Anyone who’s ever known somebody who’s had lupus cerebritis or lupus nephritis will know that those are potentially lethal diseases. “Those development programs can and should continue. We may ask for some additional safety monitoring, more to come on that,” Marks continued. #lucidquest #genetherapy #celltherapy

The Hidden Dangers of Opium Use We've just come across some important findings about primary liver cancer and opium use. In a recent study, opium users were found to be 6.5 times more likely to develop liver cancer, with this risk jumping to 11 times for long-term or high-dose users. Starting opium before age 50 significantly raises the risk, even for non-smokers. 📈 Key Findings: 1. Higher Dose, Higher Risk 2. Duration Matters 3. Early Use These findings highlight the need for greater awareness and efforts to reduce opium use for better health. For more information, please visit: https://lnkd.in/dH9354PY #PublicHealth #LiverCancer #OpiumUse #HealthResearch #CancerPrevention

Last month, the FDA announced that BCMA- or CD19-directed autologous CAR T cell therapies were under review after the agency received reports of several secondary blood cancers in patients who have been treated with them. But leading oncologists say the cancers appear to be rare and the therapy is lifesaving in the context of deadly malignancies that have already outwitted chemotherapy and radiation. This perhaps raises more questions than distinct next steps... - Should treatment regimens change in light of this FDA review? - How should providers, insurance, regulatory agencies and patients balance the risks? - Should "immortal time bias" be factored in? How should we consider the real benefits of CAR-T therapy? Curious to get your thoughts... #cartcelltherapy #fda #cancertreatment https://lnkd.in/eKujDimC.

July is #SarcomaAwarenessMonth! Synovial sarcoma is a rare type of #cancer. It is a type of soft tissue sarcoma, which are tumors that can appear in the arm, leg, foot, lung, abdomen, or near joints such as the ankle or wrist. Approximately one-third of patients are diagnosed under the age of 30. The five-year survival rate for individuals with metastatic diseases is 20%, and patients often experience reoccurrence and exhaust available treatment options. Adaptimmune Therapeutics has investigational T-cell receptor (#TCR) T-cell therapies in development targeting solid tumors, including synovial sarcoma. One therapy is letetresgene autoleucel (lete-cel), which targets a subset of individuals that who have cancer with the antigen NY-ESO-1. The other is afamitresgene autoleucel (afami-cel) which targets the MAGE-A4 antigen. Afami-cel has a US Food and Drug Administration (FDA) Prescription Drug User Fee Act (#PDUFA) decision date of August 4, 2024. Cell and gene therapies can offer additional treatment options for more patients. Know what's coming. To learn about ETS' pipeline monitoring and other services, contact us at 877.445.4822, or visit us at https://bit.ly/3Yih1dB.