docj
1 day ago
Tiny-Ad-8280
“It’s Just a Poster…” Until It Saves Lives. 40 Days...
Let’s not sugarcoat it.
“It’s just a poster.” “We’ve been here before.” “If this were real, we’d already know.”
That’s what they’re saying.
Some with cynicism.
Some with scars.
And honestly? I get it.
But if you’ve ever paid attention to oncology, you know:
The biggest revolutions start small.
And this one — if it holds — could be one of the biggest of all.
🧬 Let’s rewind to 2015
Immunomedics walked into ASCO with Trodelvy, a drug nobody cared about yet.
58 women with stage 4 triple-negative breast cancer
17 had some tumor shrinkage
2 had full tumor disappearance
No survival data
No media frenzy
Just a quiet little poster tacked to a wall
No one said,
“This changes everything.”
But five years later?
Trodelvy becomes the largest breast cancer acquisition in history.
$21 billion.
Because that poster was the spark.
It didn’t show a cure.
It showed a signal.
🧬 Now it’s 2025. And Leronlimab is bringing more than a signal.
It’s not just a tumor response.
It’s not a 3-month bump in survival.
It’s stage 4 breast cancer patients — alive and well, three years later.
It’s people who failed every line of chemo — now cancer-free.
It’s data that, if true, doesn’t just whisper “potential.”
It screams: hope is back.
Let me make this brutally clear:
✅ This is metastatic triple-negative breast cancer
✅ The kind that kills in 6–12 months, even with treatment
✅ These women were told, “There’s nothing more we can do.”
✅ And now some are alive 36+ months later, with no cancer left to find
You don’t see that.
Not in this disease.
Not at this stage.
Not ever.
📊 Let’s stack it side by side — facts only:
🧬 Trodelvy (2015) vs Leronlimab (2025)
Poster vs Poster. Hope vs Survival.
Metric Trodelvy (2015 Poster at ASCO) Leronlimab (2025 Poster at ESMO)
Trial Phase Phase 1/2 Phase 1b/2 (Basket Trial)
Patients 58 with mTNBC (chemo-refractory) 30 with mTNBC (chemo-refractory)
Tumor Shrinkage 17 of 58 (~31% response rate) Some complete responses (NED); numbers coming at ESMO
Complete Remissions 2 confirmed Confirmed NED cases; final count revealed at ESMO
Median Survival Not reported >50% alive at 12 months
Long-Term Survivors None reported 36+ monthsSome alive , cancer-free
Grade 3/4 Side Effects 39% neutropenia, 13% diarrhea (chemo-like toxicity) Zero Grade 3/4 treatment-related adverse events
Now let me decode that last line for everyone without a medical degree:
🩸 Trodelvy’s early success came with real toxicity.
4 in 10 patients developed neutropenia — dangerously low white blood cells that can lead to life-threatening infections.
Over 1 in 10 had severe diarrhea — the kind that can land you in the hospital.
These are Grade 3 or 4 side effects, the most serious in cancer trials. They’re manageable — but not easy. This is classic, brutal chemo.
🌱 Leronlimab’s early trial?
Zero of those severe, drug-related side effects reported.
Not one patient experienced life-altering toxicity due to the drug.
No fevers. No bone marrow suppression. No emergency transfusions.
Just a targeted immune modulator that — somehow — gave patients time, without taking their quality of life.
You know what that means?
These women weren’t just alive longer.
They were living longer — without suffering.
That is not normal. That is not expected. That is not pharma-as-usual.
That is a breakthrough.
“But it’s just a poster…”
Yes.
So was Trodelvy.
So were the first data points from Keytruda, from Opdivo, from every life-saving drug in oncology history.
Because posters are where revolutions begin.
And this one?
Might be the most important ever tacked to a conference wall.
TL;DR:
“We’ve seen this before.”
No. You haven’t.
You’ve seen companies chase survival.
Now you’re seeing it.
You’ve seen drugs buy patients time.
Now you’re seeing people beat the clock.
And in 40 days, on a poster board in Munich,
you’ll see the data that proves it.
So roll your eyes.
Call it hype.
Say “we’ve heard this before.”
But when those survival curves drop…
when you see “36+ months” in a disease that gives you 6…
You’ll remember this post.
And you’ll realize:
This wasn’t another story.
This was the beginning of the ending — of metastatic breast cancer.
— Tiny 🧬
docj
2 days ago
Designer_Anteater_18
Reasons to go from Phase 2 to Phase 3 colorectal trial before enrollment
How did cytodyn move its colorectal trial from a phase 2 trial to a phase 3 trial? What could have happened to have this change before enrollment?
ChatGPT said:
If CytoDyn has moved its relapsed/refractory microsatellite-stable colorectal cancer (CRC) trial from Phase 2 to Phase 3 before enrollment, several key factors could have influenced this shift:
Possible Reasons for the Change:
Strong Preliminary Data
If CytoDyn or its research partners (Syneos Health, academic institutions, or other collaborators) provided compelling preclinical or early clinical data (such as compassionate use or investigator-led studies), the FDA might have been convinced that a Phase 3 trial was justified.
Fast Track or Breakthrough Designation
If the FDA granted Fast Track, Breakthrough Therapy, or Accelerated Approval pathways, they may have allowed the trial to jump directly to Phase 3 to expedite approval.
Agreement with the FDA (End-of-Phase 2 Meeting)
CytoDyn may have had discussions with the FDA in an End-of-Phase 2 meeting, where they provided data that satisfied Phase 2 requirements and allowed for a direct transition to Phase 3.
Regulatory Strategy Change
CytoDyn might have restructured its clinical trial design (e.g., increasing sample size, modifying endpoints) to meet Phase 3 standards upfront, possibly in alignment with a potential partner’s requirements.
A Confirmatory Trial Approach
If the FDA agreed that Phase 2 endpoints were sufficient for efficacy, CytoDyn could have adjusted the trial into a pivotal Phase 3 study serving as a confirmatory trial for approval.
Potential Partnership Influence
A pharmaceutical partner (GSK, Merck, or another company) might have pushed for a direct Phase 3 trial as part of a licensing deal.
Updated Scientific Findings (CCR5 Mechanism in Oncology)
New discoveries or peer-reviewed studies supporting CCR5 inhibition in colorectal cancer might have strengthened the case for a direct Phase 3 move.
What Would This Mean for CytoDyn?
Saves time: Skipping Phase 2 saves 1-2 years in the regulatory process.
Higher valuation: A Phase 3 asset attracts more partnerships, institutional investors, and buyout interest.
Increased funding opportunities: Moving to Phase 3 suggests FDA confidence, which can help raise money from investors or government grants.
This move could be huge for CytoDyn, especially if it means leronlimab’s oncology applications are proving to be strong enough to go straight to a pivotal trial.
Monroe1
3 days ago
CytoDyn looks to get a fair shot finally ... https://news.spreely.com/rfk-jr-plans-to-eliminate-vaccine-promotion-and-hiv-prevention-offices-by-jordan-conradson/
Health and Human Services Secretary Robert F. Kennedy Jr. is making headlines with his ambitious plan to overhaul the sprawling department. As part of his bold initiative to streamline operations and cut down on government bloat, Kennedy has set in motion a plan to reduce the HHS workforce by 20,000 employees. This transformative move underscores his commitment to shrinking the size of the federal government — a principle championed by conservative icons like Ronald Reagan.
One of the most significant steps Kennedy has taken is targeting the Office of Infectious Disease and HIV/AIDS Policy (OIDP) for restructuring. This office, which has been at the forefront of promoting expansive vaccination campaigns, is set to face massive layoffs. Kennedy’s decisive action sends a clear message: under his leadership, HHS will focus on efficient, transparent, and accountable public health practices rather than perpetuating bloated bureaucratic structures.
Critics of OIDP have long argued that the office became too focused on promoting vaccine mandates without sufficiently addressing safety concerns or acknowledging adverse reactions. By downsizing OIDP, Kennedy is signaling his intent to move away from coercive health policies and toward a more balanced, evidence-based approach.
Kennedy’s efforts are a direct challenge to the controversial legacy left by Dr. Anthony Fauci at the National Institute of Allergy and Infectious Diseases (NIAID). Fauci’s tenure has been marked by widespread criticism over his handling of both the COVID-19 pandemic and the AIDS crisis. Under Fauci’s leadership, public confidence in health agencies plummeted as contradictory guidance and rushed vaccine approvals left Americans feeling uncertain and betrayed.
Particularly concerning is the fallout from the COVID-19 vaccine rollout. Critics point to thousands of deaths and severe adverse reactions linked to the vaccine, raising serious questions about the FDA’s approval process. Kennedy, who has long advocated for vaccine safety and transparency, is determined to hold public health officials accountable for pushing experimental vaccines without sufficient long-term studies.
Monroe1
6 days ago
About Merck’s research in women’s cancers
Merck is advancing research aimed at expanding treatment options for certain breast and gynecologic (ovarian, cervical and endometrial) cancers, with a goal of improving outcomes for more patients affected by these diseases. Breast cancer and gynecological cancers are the first and second most commonly occurring cancer types among women worldwide, respectively, and Merck aims to give patients facing these devastating diseases options. With more than 20 clinical trials in more than 18,000 patients around the world, Merck is driving innovative research to purposefully advance standards of care in women’s cancers. Merck’s research efforts include trials focused on evaluating its medicines in earlier stages, as well as identifying novel mechanisms and new combinations with these treatments. Merck is working to develop a portfolio and pipeline to address the impact of women’s cancers on patients, their families and communities globally.
Keytruda failed colon cancer but passed for what??? Who would approve this turda? That is the key question.
Discontinuation of KEYTRUDA due to adverse reactions occurred in 21% of 488 patients; the most common (≥1%) were increased ALT (1.6%), colitis (1%), and adrenal insufficiency (1%). The most common adverse reactions (≥20%) were musculoskeletal pain (41%), fatigue (40%), rash (30%), diarrhea (27%), pruritus (23%), and hypothyroidism (21%).
In KEYNOTE-868, when KEYTRUDA was administered in combination with chemotherapy (paclitaxel and carboplatin) to patients with advanced or recurrent endometrial carcinoma (n=382), serious adverse reactions occurred in 35% of patients receiving KEYTRUDA in combination with chemotherapy, compared to 19% of patients receiving placebo in combination with chemotherapy (n=377). Fatal adverse reactions occurred in 1.6% of patients receiving KEYTRUDA in combination with chemotherapy, including COVID-19 (0.5%) and cardiac arrest (0.3%). KEYTRUDA was discontinued for an adverse reaction in 14% of patients. Adverse reactions occurring in patients treated with KEYTRUDA and chemotherapy were generally similar to those observed with KEYTRUDA alone or chemotherapy alone, with the exception of rash (33% all Grades; 2.9% Grades 3-4).
Adverse reactions occurring in patients with MSI-H or dMMR endometrial carcinoma who received KEYTRUDA as a single agent were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a single agent.
Adverse reactions occurring in patients with TMB-H cancer were similar to those occurring in patients with other solid tumors who received KEYTRUDA as a single agent.
Adverse reactions occurring in patients with recurrent or metastatic cSCC or locally advanced cSCC were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.
In KEYNOTE-522, when KEYTRUDA was administered with neoadjuvant chemotherapy (carboplatin and paclitaxel followed by doxorubicin or epirubicin and cyclophosphamide) followed by surgery and continued adjuvant treatment with KEYTRUDA as a single agent (n=778) to patients with newly diagnosed, previously untreated, high-risk early-stage TNBC, fatal adverse reactions occurred in 0.9% of patients, including 1 each of adrenal crisis, autoimmune encephalitis, hepatitis, pneumonia, pneumonitis, pulmonary embolism, and sepsis in association with multiple organ dysfunction syndrome and myocardial infarction. Serious adverse reactions occurred in 44% of patients receiving KEYTRUDA; those ≥2% were febrile neutropenia (15%), pyrexia (3.7%), anemia (2.6%), and neutropenia (2.2%). KEYTRUDA was discontinued in 20% of patients due to adverse reactions. The most common reactions (≥1%) resulting in permanent discontinuation were increased ALT (2.7%), increased AST (1.5%), and rash (1%). The most common adverse reactions (≥20%) in patients receiving KEYTRUDA were fatigue (70%), nausea (67%), alopecia (61%), rash (52%), constipation (42%), diarrhea and peripheral neuropathy (41% each), stomatitis (34%), vomiting (31%), headache (30%), arthralgia (29%), pyrexia (28%), cough (26%), abdominal pain (24%), decreased appetite (23%), insomnia (21%), and myalgia (20%).
In KEYNOTE-355, when KEYTRUDA and chemotherapy (paclitaxel, paclitaxel protein-bound, or gemcitabine and carboplatin) were administered to patients with locally recurrent unresectable or metastatic TNBC who had not been previously treated with chemotherapy in the metastatic setting (n=596), fatal adverse reactions occurred in 2.5% of patients, including cardio-respiratory arrest (0.7%) and septic shock (0.3%). Serious adverse reactions occurred in 30% of patients receiving KEYTRUDA in combination with chemotherapy; the serious reactions in ≥2% were pneumonia (2.9%), anemia (2.2%), and thrombocytopenia (2%). KEYTRUDA was discontinued in 11% of patients due to adverse reactions. The most common reactions resulting in permanent discontinuation (≥1%) were increased ALT (2.2%), increased AST (1.5%), and pneumonitis (1.2%). The most common adverse reactions (≥20%) in patients receiving KEYTRUDA in combination with chemotherapy were fatigue (48%), nausea (44%), alopecia (34%), diarrhea and constipation (28% each), vomiting and rash (26% each), cough (23%), decreased appetite (21%), and headache (20%).
Lactation
Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for 4 months after the last dose.
THINKING THEY NEED LERONLIMAB BIGLY.
NOW THEY GO FROM INTRAVENOUS TO INJECTION.... CLAIMING IMPROVEMENT LEADING TO APPROVAL
https://finance.yahoo.com/news/positive-phase-iii-data-gives-merck-potential-boost-for-blockbuster-keytruda-in-injection-form-150009481.html
ATTN: MERCK HAS CLOUT BUT REAL PROBLEMS WITH THEIR SEMI EFFECTIVE NOT TOO SAFE OF A DRUG. THE COMPETITION IS GOING TO WANT TO JUMP ON LERONLIMAB IF MERCK FAILS TO.... ALL IMO OF COURSE.
$$$$CYDY$$$$ 2025 LOVING IT