docetaxel (ANX-514) / Savara - LARVOL DELTA

Placebo-Controlled Randomized Phase II Trial of Docetaxel with or without Intravenous Vitamin C for Metastatic Castrate-Resistant Prostate Cancer (SIO-Canada 2023) - P=2 | N=50 | "Initial concurrent high-dose IV vitamin C with docetaxel did not improve PSA response or toxicity, or clinical outcomes. MCRPC patients receiving docetaxel should be advised against seeking concurrent high-dose IV vitamin C."

P2 data

Wakelee Addresses NSCLC Treatment Considerations From Every Angle (OncLive) - "Giving a glimpse into significant data and highlighting the importance of balancing toxicities with efficacy as the non-small cell lung cancer treatment paradigm shifts....'It'll be great at the Hawaii meeting to talk about what do all these [data] mean in the context of a patient who comes in to see you and how we make our decisions,' Wakelee said."

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AMBER: Anti-TIM3 Antibody Reverses T-cell Exhaustion in NSCLC (YouTube) - "Diwakar Davar, MD...discusses findings from the AMBER trial (NCT02817633) of cobolimab, an anti-TIM-3 monoclonal antibody, alone or with PD-1 inhibitors in patients with non-small cell lung cancer (NSCLC). Cobolimab plus dostarlimab combination therapy in patients with NSCLC previously treated with anti-PD(L)-1 therapy returned some evidence of efficacy and progression-free survival with responders having higher expression of TIM3...This interview took place at the Society for Immunotherapy of Cancer's (SITC) 38th Annual Meeting in San Diego, CA."

Interview • Video

Tusamitamab ravtansine (anti-CEACAM5 ADC) does not improve PFS over 2L docetaxel in NSCLC with high CEACAM5 expression in the phase III CARMEN-LC03 trial. Sanofi discontinues development of tusamitamab ravtansine.

P3 data

My view: docetaxel is like a cockroach that remains alive after everything else is destroyed in a nuclear winter. We don't like it, but it's amazingly difficult to vanquish.

Wow- the docetaxel enigma continues Admittedly with a 20% or so RR in CEACAM5 high+ patients + ocular tox concerns, road did not seem easy for tusamitamab..

Promising ADCs Emerge in Non-Small Cell Lung Cancer (Targeted Oncology) - '"There is a lot of excitement surrounding the potential of ADCs and it's attributable to how they are made because these agents are not antibodies entirely, and they are not chemotherapy, and yet, they are both,' Karen L. Reckamp, MD, MS, said...Further, some ADCs have specific biomarkers that they target, such as MET or carcinoembryonic antigen-related cell adhesion molecule 5 [CEACAM5], and there are some ADCs that are agnostic to biomarkers,' Reckamp....Although development of ADCs is promising, in community practice, the issue of toxicity is paramount, said Reckamp....'I think that's where we see things like interstitial lung disease and cardiac toxicity,' Reckamp said. 'So, for example, the TROP-2 inhibitors can cause stomatitis that tends to be different from the stomatitis that we [traditionally] associate with chemotherapy.'"

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Hossein Borghaei, DO, on Nonsquamous NSCLC: Findings on Sitravatinib Plus Nivolumab vs Docetaxel (THE ASCO POST) - P3 | N=NA | SAPPHIRE (NCT03906071) | Sponsor: Mirati Therapeutics Inc. | "Hossein Borghaei, DO...discusses phase III findings from the SAPPHIRE study of sitravatinib plus nivolumab vs docetaxel in patients with previously treated, advanced nonsquamous non-small cell lung cancer (NSCLC) (Abstract LBA63)."

P3 data • Video

How to Think About Second-Line Therapy in NSCLC (Medscape) - "I think the first thought is that, for all the regimens that are available and tested, the results are clearly not as good as seen with first-line therapy. I'll get into some specifics in a second. That being the case, it's really important to make the best choice for first-line therapy."

Video

Data Continue to Support Triplet Therapy With ADT, AR-Targeted Therapy, and Chemotherapy in mHSPC (OncLive) - "In an interview with OncLive, Zarrabi...discussed the emergence of triplet therapy of ADT, AR-targeted therapy, and cytotoxic chemotherapy for patients with mHSPC; highlighted key trials that have explored and supported the use of these triplets; and expanded on the unanswered questions that remain regarding patient selection and chemotherapy eligibility."

Interview

Precision Medicine and Immunotherapy in mNSCLC: Bridging Gaps for Patients Without Driver Mutations : Episode 5 : Overcoming Diversity Challenges and Exploring Immune Checkpoint Inhibitor Strategies in mNSCLC Treatment (AJMC) - "I do remember the original docetaxel trials had to be 20-plus years ago and to the extent that we've had a number of new agents that have been tested in the second-line setting against docetaxel, which remains a regulatory standard, although in my practice, most of the time I will use docetaxel plus ramucirumab in that setting. Do you have any particular new agent in that setting? And we recently had a press release about a Trop-2 ADC [antibody-drug conjugate] in that setting. So we may move finally beyond the docetaxel age if you will."

Checkpoint inhibition • Media quote

Trial of ADT + ARPI vs. ADT + ARPI + docetaxel is needed; meanwhile ➡️disease & pt characteristics, Rx toxicities may guide #mHSPC #prostatecancer treatment selection @urotoday @PCFnews

PDS Biotech Announces Acceptance of Abstract on Combination of PDS0301 with Docetaxel in Metastatic Prostate Cancer for Oral Presentation by the National Cancer Institute at Cytokines 2023 (Yahoo Finance) - "Combining an IL-12-based Immunocytokine (PDS0301) with Docetaxel in Metastatic Prostate Cancer: Preliminary Safety and Immune Data."

Chemotherapy Utilized in Pretreated Metastatic Castration-Resistant Prostate Cancer : Episode 9: Physicians Discuss Targeted Treatment for Prostate Cancer Subtypes (Targeted Oncology) - "In the second article of a 2-part article series, Joshua Lang, MD, and live event participants discuss the role of cabazitaxel for the treatment of patients with prostate cancer who harbor certain mutations or have other factors that make their disease unique."

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Analyzing Quality of Life and Survival from CHAARTED Prostate Cancer Trial - Daniel Sentana Lledo (Urotoday) - "Alicia Morgans...discuss a groundbreaking analysis on data from the CHAARTED study that examined how quality of life impacts survival in metastatic hormone-sensitive prostate cancer patients."

Video

Tumor Treating Fields May Provide Additional Treatment Option for mNSCLC Following Progression (IASLC Lung Cancer News (ILCN)) - "Dr. Leal described tumor treating fields as electric fields that exert physical forces on electrically charged intracellular components to disrupt mitosis, which in turn leads to aneuploidy and induction of endoplasmic reticulum stress. The downstream effects of this include immunogenic cell death, which triggers a systemic anti-tumor immune response....However, as discussant Rebecca Suk Heist, MD...pointed out, there are unanswered questions. 'The major caveat for me is that the study design does not reflect the current standard of care,' Dr. Heist said."

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Radiation plus intensive systemic therapy improves outcomes in prostate cancer subset (Healio) - "Over the past decade, treatment for de novo metastatic prostate cancer has moved toward a 'more is better' approach, with evidence showing doublets of ADT chemotherapy (docetaxel) or novel hormone therapies (abiraterone, enzalutamide [Xtandi; Astellas, Pfizer], apalutamide [Erleada, Janssen] and darolutamide [Nubeqa, Bayer]) with chemotherapy conferring better outcomes than ADT alone. Further studies suggested a triplet of abiraterone and olaparib (Lynparza; AstraZeneca, Merck) perform better than doublets for patients with BRCA alterations."

Online posting

Treatment Intensification With Darolutamide in Metastatic Prostate Cancer - Benefits consistent across disease-volume and risk subgroups (MedPageToday) - "As Maha Hussain, MD...reported in the Journal of Clinical Oncology, 1,305 patients were randomly assigned to darolutamide or placebo plus androgen-deprivation therapy (ADT) and docetaxel. Of these, 1,005 (77%) had high-volume disease and 912 (70%) had high-risk disease."

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Asco 2023 – Novocure Sinks as Lunar’s Limitations Become Clear (Evaluate) - "...Dr Rebecca Heist, who discussed the data for Asco after the study presentation, was unconvinced. 'The major caveat for me is that the study design does not reflect the current standard of care,' she told the meeting....'It's a positive trial,' Dr Jyoti Patel...told Evaluate Vantage on the sidelines of Asco. 'However, its relevance to the majority of patients in 2023 is yet to be demonstrated, with [standard of care seeing] the incorporation of novel targeted therapies and better immunotherapies.'...Dr Lauren Byers...agreed, telling Vantage that she did not expect Novocure's therapy to be routinely incorporated into practice with the current data."

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Tumor-treating fields extend OS in metastatic NSCLC (Healio) - "'The LUNAR study led to statistically significant and clinically meaningful improvement in overall survival, addressing a population of patients with advanced NSCLC in second line and beyond with high unmet need,' Ticiana Leal, MD...told Healio....Additional studies are underway to assess TTFields with current standard-of-care therapy as first-line treatment for metastatic and locally advanced NSCLC, Leal said."

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Liquid Biopsy Characterizing CTCs Can Aid in Treatment Selection - "'Hormonal agents prolong the lives of men with castrate-resistant prostate cancer. The optimal sequence of agents to maximize survival is unknown. It is not known if a taxane would be more beneficial after an androgen receptor-directed therapy. We need biomarkers that can be used each time a treatment decision is needed,' explained Howard Scher, MD...."

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Triplet therapy effective for metastatic prostate cancer subset regardless of disease volume (Healio) - "Treatment intensification with darolutamide plus androgen deprivation therapy and docetaxel improved OS among men with metastatic hormone-sensitive prostate cancer regardless of disease volume or risk, according to study results....Healio spoke with Maha H. A. Hussain...about the findings and their implications."

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2023 AUA preview: Dr. Cookson on top research in prostate cancer (Urology Times) - "Michael S. Cookson, MD, MMHC, highlights 5 studies in prostate cancer being presented at the 2023 American Urological Association Annual Meeting."

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A Treatment Option for Patients with mNSCLC Whose Disease Has Progressed on a Platinum-containing Regimen (VuMedi) - "Treatment discontinuation of all study drugs due to adverse reactions occurred in 13% of CYRAMZA with erlotinib-treated patients, with increased alanine aminotransferase (1.4%) and paronychia (1.4%) being the most common. The most common adverse reactions leading to treatment discontinuation of CYRAMZA were proteinuria (8.6%) and hyperbilirubinemia (6%)."

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Additional Advances in Non–Small Cell Lung Cancer Research and Clinical Trials With Ticiana Leal, MD (Oncology Data Advisor) - "Dr. Leal sat down with Oncology Data Advisor to provide an update on the rapidly evolving field of NSCLC immunotherapy."

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