Pharmaceutical Technology

SEPTEMBER 13, 2022

Hormone receptor-positive/human epidermal growth factor negative (HR+/HER2-) breast cancer accounts for approximately 70% of all breast cancers, with close to 40,000 new cases diagnosed each year worldwide. Trop-2 is highly expressed across multiple cancer types, with expression detected in more than 90% of breast cancers.

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BioSpace

SEPTEMBER 21, 2023

The companies’ antibody-drug conjugate improved progression-free survival with a “trend in improvement” for overall survival in patients with HR-positive, HER2-low or negative breast cancer.

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Pharmaceutical Technology

JULY 25, 2022

AstraZeneca and Daiichi Sankyo have received Priority Review for their supplemental Biologics License Application (sBLA) from the US Food and Drug Administration (FDA) of antibody-drug conjugate (ADC), Enhertu (trastuzumab deruxtecan), to treat unresectable or metastatic HER2-low breast cancer in adults.

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pharmaphorum

DECEMBER 9, 2022

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate (ADC) Enhertu is already making waves in breast cancer, and clinical results presented at the San Antonio Breast Cancer Symposium (SABCS) suggest they may see success with a second.

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The Pharma Data

MARCH 7, 2022

Nasdaq: GILD) today announced results from the Phase 3 TROPiCS-02 study evaluating Trodelvy ® (sacituzumab govitecan-hziy) in patients with HR+/HER2- metastatic breast cancer who received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy. Gilead Sciences, Inc.

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Pharmaceutical Technology

MARCH 6, 2023

New data for TopAlliance Biosciences/ Coherus Biosciences’ anti-PD-1 monoclonal antibody Tuoyi (toripalimab) in combination with chemotherapy suggest that it can become the next standard of care in the frontline setting. months for the chemotherapy arm (hazard ratio [HR]: 0.52). At a median follow-up of 22.1 months versus 8.2

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pharmaphorum

AUGUST 15, 2022

At this year’s ASCO congress, the Trop2-targeting antibody-drug conjugate (ADC) was found to improve progression-free survival significantly in in patients with hormone receptor-positive, HER2-negative metastatic breast cancer who received multiple lines of prior treatment.

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XTalks

NOVEMBER 20, 2023

AstraZeneca has won its first-in-class approval for its AKT inhibitor Truqap (capivasertib) in combination with Faslodex (fulvestrant) for treating patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. It was also given FDA priority review. billion to $1.28

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The Pharma Data

FEBRUARY 21, 2022

Enhertu is a HER2-directed antibody drug conjugate (ADC) being jointly developed by AstraZeneca and Daiichi Sankyo. 1,2 HER2-low expression occurs in both HR-positive and HR-negative disease.3. The primary endpoint of DESTINY-Breast04 is PFS in patients with HR-positive disease based on blinded independent central review (BICR).

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The Pharma Data

DECEMBER 29, 2020

First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. NASDAQ: REGN) today announced encouraging initial data from an ongoing Phase 1/2/3 clinical trial of the Regeneron antibody cocktail, casirivimab and imdevimab, in hospitalized COVID-19 patients requiring low-flow oxygen. futility analysis).

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XTalks

FEBRUARY 7, 2023

HR+/HER2- breast cancer is the most common type of breast cancer, with the National Cancer Institute (NCI) estimating 287,850 new cases of female breast cancer in 2022 alone. Despite decades of advances, people living with pre-treated HR+/HER2- metastatic breast cancer need new treatment options. months vs. 11.2

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The Pharma Data

APRIL 27, 2022

1-4 Low HER2 expression occurs in both HR-positive and HR-negative disease. 6 Currently chemotherapy remains the only treatment option for patients with HR-positive tumours following progression on endocrine (hormone) therapy. 7 Few targeted options are available for those who are HR-negative.

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pharmaphorum

OCTOBER 12, 2022

The US regulator has granted a priority review for Trodelvy (sacituzumab govitecan) as a treatment for adults with unresectable locally advanced or metastatic HR+/HER2- breast cancer who have progressed on endocrine-based therapy and at least two additional systemic therapies, based on the results of the recently-reported TROPiCs-02 trial.

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The Pharma Data

MARCH 18, 2022

Opdualag is a first-in-class, fixed-dose dual immunotherapy combination treatment of the PD-1 inhibitor nivolumab and novel LAG-3-blocking antibody relatlimab 1. to 5.6); (Hazard Ratio [HR] 0.75; 95% CI: 0.62 1 Relatlimab (in combination with nivolumab) is the first LAG-3-blocking antibody to demonstrate a benefit in a Phase 3 study.1

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pharmaphorum

SEPTEMBER 9, 2022

At this year’s ASCO congress, news that Trodelvy (sacituzumab govitecan) failed to have a significant impact on overall survival (OS) in this form of breast cancer weighed heavily on Gilead, as the Trop2-targeting antibody-drug conjugate (ADC) is central to its plans to grow in oncology.

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pharmaphorum

JUNE 6, 2022

The trial evaluated Trodelvy (sacituzumab govitecan) in patients with HR-positive, HER2-negative metastatic breast cancer who received multiple lines of prior treatment, and showed that the drug extended progression-free survival to 5.5 At ASCO the numbers have been revealed, and the picture isn’t much clearer.

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pharmaphorum

APRIL 25, 2022

The Swiss pharma said in its update that the acelERA trial comparing giredestrant to physician’s choice of endocrine therapy for previously-treated hormone receptor (HR)-positive, HER2-negative breast cancer did not meet its primary endpoint of improving progression-free survival (PFS). Diagnostic led the charge, rising 24% to CHF 5.3

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pharmaphorum

SEPTEMBER 15, 2020

The agreement with Immunommedics adds Trodelvy (sacituzumab govitecan) to Gilead’s pipeline, a first-in-class TROP2 antibody-drug conjugate drug. California-based Gilead announced its strong intentions in oncology in 2017 with its $11.9

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pharmaphorum

AUGUST 8, 2022

It has the potential to be a sizeable new indication for Enhertu (trastuzumab deruxtecan), a HER2-targeting antibody-drug conjugate, and central to AZ and Daiichi Sankyo’s hopes of unlocking multibillion-dollar sales for the drug.

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XTalks

FEBRUARY 5, 2024

Why it did so well: Darzalex was the first human anti-CD38 monoclonal antibody approved by the FDA for multiple myeloma. It is prescribed for the treatment of metastatic breast cancer in patients with HR-positive/HER2-negative status. Darzalex (Daratumumab) Darzalex 2022 Sales: $7.977 billion Company/Developer: Janssen Biotech, Inc.,

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The Pharma Data

SEPTEMBER 14, 2020

The primary focus of the deal for Gilead is Immunomedics’ Trop-2 directed antibody-drug conjugate Trodelvy (sacituzumab govitecan-hziy), which it scoops up as part of the agreement. The company aims to pursue full US approval towards the end of this year, with a European application to follow in the first half of 2021.

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XTalks

SEPTEMBER 17, 2020

Trodelvy is being studied in an ongoing Phase III trial as third line treatment for HR+/HER2- breast cancer and a Phase II study in bladder cancer. Trodelvy is an antibody-drug conjugate (ADC). Additionally, it is being studied for non-small cell lung cancer and other solid tumor types.

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pharmaphorum

FEBRUARY 14, 2022

Around half of all patients with MIBC are unable to be treated with cisplatin, a strategy which has been shown to improve the chances of survival, and the results suggest Padcev – an anti-nectin-4 antibody-drug conjugate – could offer an alternative.

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The Pharma Data

JUNE 26, 2021

All current COVID-19 vaccines and antibody-based therapeutics were designed to disrupt this route into cells, which requires a receptor called ACE2. The ability to use an alternative entry pathway opens up the possibility of evading COVID-19 antibodies or vaccines, but the researchers did not find evidence of such evasion.

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The Pharma Data

MARCH 15, 2021

months for chemotherapy (n=304); hazard ratio (HR): 0.69; 95% confidence interval (CI): 0.56-0.84 months for chemotherapy (n=238); HR: 0.73; 95% CI: 0.58-0.91 months for chemotherapy (n=66); HR: 0.56; 95% CI: 0.36-0.85 Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells.

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The Pharma Data

JUNE 29, 2021

KEYTRUDA plus 5-FU and cisplatin reduced the risk of death by 27% (HR=0.73 [95% CI, 0.62-0.86]; 0.86]; p<0.0001) and reduced the risk of disease progression or death by 35% (HR=0.65 [95% CI, 0.55-0.76]; 10) (n=383/749), KEYTRUDA plus 5-FU and cisplatin reduced the risk of death by 38% (HR=0.62 [95% CI, 0.49-0.78];

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The Pharma Data

JUNE 25, 2021

41.5), KEYTRUDA demonstrated a statistically significant and clinically meaningful reduction in the risk of disease recurrence or death by 32% compared to placebo (HR=0.68 [95% CI, 0.53–0.87]; After a median follow-up of 24.1 months (14.9-41.5), 0.87]; p=0.0010). 0.96]; p=0.0164). 0.87]; p=0.0010). with KEYTRUDA versus 68.1% with placebo.

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HR Trials Clinical Research Research 52

The Pharma Data

JANUARY 14, 2021

HR (95% CI): 0.68. HR (95% CI): 0.54 (0.33, 0.87). HR (95% CI): 0.44 (0.25, 0.77). HR (95% CI): 0.58; (0.35, 0.95); p=0.027. HR (95% CI): 0.44 (0.25, 0.77). HR (95% CI): 0.58; (0.35, 0.95); p=0.027.

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XTalks

MARCH 22, 2021

The biotech acquisition deal includes Five Prime’s prime asset bemarituzumab, which is a first-in-class anti-FGFR2b antibody. The antibody accrued promising data in a randomized, placebo-controlled Phase II study in frontline advanced gastric or gastroesophageal junction (GEJ) cancer, and is now being prepared for Phase III trials.

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The Pharma Data

APRIL 11, 2021

Patients treated with this combination had a decrease in risk of disease progression or death by 48% (HR=0.52, p=0.000002) compared to patients treated with placebo and rituximab, with a median PFS of 21.5 Patients must have relapsed after the last rituximab-, rituximab biosimilars-, or anti-CD20 monoclonal antibody (e.g.,

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The Pharma Data

MARCH 17, 2021

KEYTRUDA reduced the risk of disease progression or death by 35% (HR=0.65 [95% CI, 0.48-0.88]; In KEYNOTE-204, KEYTRUDA reduced the risk of disease progression or death by 35% (HR=0.65 [95% CI, 0.48-0.88]; 0.88]; p=0.0027) and showed a median PFS of 13.2 months versus 8.3 months for patients treated with BV. months (95% CI, 10.9-19.4)

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The Pharma Data

MARCH 20, 2021

The vast majority of current laboratory testing for COVID-19 is based either on detection of viral antigens, nucleic acids or on detection of virus-specific antibodies in the sera of patients. Detection of virus-specific antibodies allows for diagnosis of recent symptomatic or even asymptomatic infections.

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Protein Antibody Development RNA 52

The Pharma Data

SEPTEMBER 10, 2021

Patients treated with a short course of five cycles of tremelimumab, an anti-CTLA4 antibody, over 16 weeks in addition to Imfinzi and chemotherapy experienced a 23% reduction in the risk of death versus a range of chemotherapy options (based on a hazard ratio [HR] of 0.77; 95% CI 0.65-0.92; 0.92; p=0.00304). Median OS was 14.0

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The Pharma Data

MARCH 2, 2021

Key secondary endpoints included overall survival and MRD response, AEs, 100-day mortality after alloHSCT, incidence of anti-blinatumomab antibody formation, cumulative incidence of relapse. Key secondary endpoints include overall survival of HR, IR, and LR relapsed B-ALL patients.

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The Pharma Data

SEPTEMBER 9, 2020

Food and Drug Administration (FDA) for adults with anti-aquaporin-4 (AQP4) antibody positive NMOSD. In a separate pooled analysis, ENSPRYNG reduced the risk of relapse in the combined double-blind period and open-label extension (OLE) by 51% (HR, 0.49; 95% CI, 0.31–0.79; ENSPRYNG was recently approved by the U.S.

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The Pharma Data

JULY 15, 2021

After a median follow-up of 39 months, the KEYTRUDA regimen reduced the risk of EFS events by 37% (HR=0.63 [95% CI, 0.48-0.82]; 1, treatment with the KEYTRUDA regimen reduced the risk of EFS events by 33% (HR=0.67 [95% CI, 0.49-0.92]) 1.02]; p=0.03214). 0.92]) versus the chemotherapy-placebo regimen.

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The Pharma Data

SEPTEMBER 16, 2020

Data will also be presented for two of our investigational hormone receptor (HR)-positive breast cancer treatments, both of which target the PI3K/AKT signalling pathway, a key driver of cancer cell growth and proliferation. HR-positive breast cancer. GDC-0077 is our next generation investigational PI3K? Ipatasertib. Real world data.

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