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When Jeannette Cleland learned earlier this year that she could get chemotherapy at home, after dropping a particularly toxic medication, it seemed like good news. But then Cleland, a 44-year-old Minneapolis event planner who has stage 4 pancreatic cancer, did the math. Read the rest…
FDA’s Oncologic Drugs Advisory Committee acknowledged that Imfinzi met its primary endpoint of event-free survival in the treatment of resectable non-small cell lung cancer.
Epicur Pharma’s Advisory Council member Ann Donoghue, DVM, MS shares her personal perspective on the important relationship between veterinary oncology and compounded medications used in chemotherapy treatments. Many of the presentations discussed the chemotherapies available to treat dogs.
Additionally, when compared to patients in the control arm, patients in the vibostolimab and pembrolizumab fixed-dose combination arm experienced a higher rate of adverse events (AEs) and immune-related AEs. At a pre-planned analysis, data showed that the primary endpoint of overall survival (OS) met the pre-specified futility criteria.
The National Institute for Health and Care Excellence (NICE) has recommended the use of KEYTRUDA (pembrolizumab) as an option with chemotherapy for neoadjuvant, and alone as adjuvant treatment after surgery, for adults with early TNBC, at high risk of recurrence, or locally advanced TNBC. After a median follow-up of 39.1
In addition, A Phase III trial of Ivonescimab plus chemotherapy versus chemotherapy in epidermal growth factor receptor (EGFR) mutated advanced non-squamous NSCLC that failed in prior epidermal growth factor receptor EGFR tyrosine kinase inhibitors (TKIs) therapy is ongoing. percent and a median progression-free survival (mPFS) of 8.2
Data from the phase 3 ASCENT study showed Trodelvy (sacituzumab govitecan) significantly extended overall survival (OS) and improved overall response rate (ORR) and clinical benefit rate (CBR), compared with standard chemotherapy in TNBC patients with brain metastases treated with at least two therapies. in the chemotherapy arm.
The process starts with chemoimmunotherapy, and if a patient responds to and can tolerate further treatment, they move on to high-dose chemotherapy (HDT) followed by a stem cell transplant (ASCT). 3 cytokine release syndrome (CRS) and neurologic events were observed in 6 percent and 21 percent of patients, respectively. months vs 2.0
The landmark trial has demonstrated event-free survival (EFS), the primary endpoint, that is superior to historical SOC treatment. Historical SOC involves platinum-based salvage combination chemoimmunotherapy regimen followed by high-dose therapy (HDT) and stem cell transplant (ASCT) in patients who respond to salvage chemotherapy.
The latest approval is based on positive data from the multicentre, double-blind, randomised, placebo-controlled Phase III ARASENS clinical trial that analysed the safety and efficacy of oral darolutamide plus androgen deprivation therapy (ADT) and the chemotherapy docetaxel in mHSPC patients.
months in patients with high PD-L1 expression compared with standard chemotherapy. Grade 3–4 treatment-related adverse events were reported in 12.9% of people receiving chemotherapy. Approval is based on Roche’s phase 3 Impower110 study which showed Tecentriq monotherapy improved overall survival by 7.1
Approval for Opdivo was based on results from the CheckMate-77T trial, which demonstrated that the combination significantly improved event-free survival and pathologic complete response in adults with resectable non-small cell lung cancer without EGFR or ALK rearrangements.
The biologic ZL-1310 is being investigated in an ongoing Phase Ia/Ib study in these patients who have had at least one platinum-based chemotherapy regimen. The monoclonal antibody therapy was reported to be well tolerated, with most treatment emergent adverse events (TEAE) Grade 1 or 2, according to the findings.
months and an objective response rate (ORR) of 48%, both exceeding what is typical for the standard of care of gemcitabine + nab-paclitaxel suggesting potential complementary activity with the existing FDA-approved standard chemotherapy regimen.
Phase III CheckMate -77T trial data show statistically significant improvements in event-free survival with Opdivo (nivolumab) plus chemotherapy followed by surgery and adjuvant Opdivo in the treatment of resectable stage IIA to IIIB non-small cell lung cancer.
In May, a Phase 2 study started, comparing Kaiku’s electronic patient-reported outcome (ePRO) approach to evaluating immune-related adverse events to the standard model of care in cancer patients treated with checkpoint inhibitor drugs, with results due towards the end of 2023 or in early 2024.
Moreover, this NCE did not present any adverse events in the first cohort. This drug is our lead candidate for treating patients with TNBC and prostate cancer, and enhances the efficacy of standard-of-care chemotherapy”, said Dr Sangeeta Srivastava, Executive Director, Godavari Biorefineries Limited and CSO, Sathgen Therapeutics.
Results from the Phase III CheckMate -77T trial show that Opdivo (nivolumab) plus chemotherapy followed by surgery and adjuvant Opdivo produced statistically significant and clinically meaningful improvements in event-free survival in patients with resectable stage IIA to IIIB non-small cell lung cancer.
Compared to placebo plus chemotherapy, nivolumab plus chemotherapy had also improved event-free survival and both polymerase chain reaction and major pathologic response rates.
The patient then receives chemotherapy to reduce regulatory T cells that can put a brake on immune responses to tumours, as well as immune-boosting cytokine interleukin-2, before the TILs are then reinfused into the patient intravenously.
The filing is based on findings of the innovaTV 204 phase 2 single-arm trial, in 101 patients with recurrent or metastatic disease previously treated with doublet chemotherapy and Roche’s Avastin (bevacizumab) if appropriate.
The late stage data showed Padcev significantly improved overall survival compared with chemotherapy in a group of patients previously treated with platinum chemo and and a PD-1/L1 inhibitor. months in patients treated with Padcev compared with nine months in those treated with chemotherapy. months in the chemotherapy group.
Patients with resectable stage II, IIIA, and IIIB (T3-4N2) disease of both squamous and non-squamous histology were randomized to receive neoadjuvant Keytruda with platinum-based chemotherapy followed by adjuvant Keytruda, or placebo with platinum-based chemotherapy followed by placebo. At a median duration of follow-up of 25.2
Now, results from the ongoing TRANSFORM study show that Breyanzi was more effective than the standard second-line treatment – salvage therapy followed by high-dose chemotherapy and a stem cell transplant – at fending off disease recurrence.
The combined therapy includes toripalimab plus chemotherapy as peri-operative treatment and toripalimab monotherapy as consolidation therapy following adjuvant therapy. During the trial, patients with operable NSCLC were given toripalimab or a placebo along with platinum-based doublet chemotherapy as neoadjuvant and adjuvant therapy.
Breyanzi Phase III trial results In the Phase III TRANSFORM trial , Breyanzi more than quadrupled median event-free survival (EFS) compared to standard therapy with a median follow-up of 6.2 Standard care was determined as salvage immunochemotherapy followed by high-dose chemotherapy and hematopoietic stem cell transplant (HSCT).
The ORR and OS metrics surpassed the standard of care of gemcitabine plus nab-paclitaxel, and indicated potential complementary activity with the current standard chemotherapy regimen approved by the FDA.
The first-look data from the phase 1/2 trial revealed no drug-related serious adverse events, positive effects on IDUA biomarkers in the CNS, as well as preliminary evidence of improved neurodevelopment. With RGX-111, Regenxbio hopes to offer a one-shot treatment that delivers a functional copy of the IDUA gene to cells in the CNS.
The key opinion leaders (KOLs) interviewed by GlobalData highlighted that tolerability remains a highly sought-after quality with developing therapies, as highly prescribed chemotherapies containing oxaliplatin often lead to serious adverse events and discontinuation.
Patients in the US and EU with recurrent or metastatic nasopharyngeal carcinoma (NPC), a subtype of head and neck squamous cell carcinoma (HNSCC), are mostly treated with a combination of chemotherapy agents in the frontline setting, such as cisplatin + gemcitabine. months for the chemotherapy arm (hazard ratio [HR]: 0.52).
In ZUMA-7, second-line treatment of relapsed or refractory LBCL patients with Yescarta extended median event-free survival (EFS) to 8.3 LBCL is the most common type of non-Hodgkin’s lymphoma (NHL) in adults, accounting for around a third of the 77,000 new cases diagnosed in the US.
Event-free survival (EFS) was the primary endpoint in this study, with the neoadjuvant arm reporting a two-year EFS of 72% in comparison to the 49% reported for the adjuvant arm. Overall survival (OS) data remains immature, with too few events for statistical analysis. MSI-H/dMMR CRC accounts for 10-15% of all CRC.
The trial was recommended to continue to analyze event-free survival rates, but current results are encouraging for treating estrogen receptor-positive, human epidermal growth factor receptor 2-negative breast cancer.
Axcynsis Therapeutics CEO Dr Zou Bin said: This is a transformational event for Axcynsis and a significant milestone for our proprietary ADC platform using AxcynDOT. AxcynDOT, the companys payload, is a derivative of trabectedin, a chemotherapy approved in the US, Europe, and certain Asian countries.
Study authors determined that prevention or mitigation of myelotoxic events that destroy bone marrow can potentially lessen myelosuppression in patients with ES-SCLC.
The study also evaluated VANFLYTA in combination with standard cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation. It enrolled 539 adult patients aged 18 to 75 years from 193 study sites across Asia, North America, Europe, Oceania and South America.
The AGILE trial, which compared the combination of Tibsovo (ivosidenib) and Bristol-Myers Squibb’s chemotherapy Vidaza (azacitidine) to Vidaza plus placebo as a first-line therapy for IDH1-positive AML, showed a three-fold improvement in overall survival. for the Tibsovo are and 14.9% for the control group. for the control group.
As a result, when the patient’s lymphoma relapses after treatment with chemotherapy, BV and CPIs, there are no effective treatment alternatives for these patients. The majority of patients experienced only mild to moderate treatment-related adverse events, confirming a well-manageable safety profile.
In the phase 3 BELINDA trial, Kymriah (tisagenlecleucel) was unable to extend event-free survival wen used as a second-line therapy for aggressive B-cell lymphoma, dashing Novartis’ hopes of extending its current use in patients who have relapsed after receiving two lines of therapy.
Two months later, it missed the mark in another mid-stage study as a second-line monotherapy for biliary tract cancer (BTC), which was followed in August by a third failure as a first-line treatment alongside chemotherapy in locally advanced or metastatic BTC. billion takeover of Tesaro in 2019.
To illustrate, in the management of nausea and vomiting induced by cytotoxic chemotherapy or radiotherapy, the dose of IV granisetron is 10 mcg/kg in Lexicomp , but 10-40 mcg/kg (max per dose 3mg) in British National Formulary.
CTX001 treatment has its limitations, however, not least that patient have to undergo myeloablative chemotherapy with a busulfan-based regimen followed by transplant with the CRISPR-modified cells back into the bone marrow. There have also ben no cases of cancer – a concern with bluebird’s gene therapy approach.
According to GlobalData, the latest event to affect Ondansetron hydrochloride CR’s likelihood of approval (LoA) and phase transition for Diarrhea took place on 21 Nov 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.
Those immunologically cold gastrointestinal tumours present a real clinical challenge, with a standard of care heavily relying on chemotherapy approaches. No serious adverse events were observed. It is worth noting that patients with r/r PaC or r/r MSS-CRC have very limited treatment options.
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