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.

HR 130

HR Hormones Clinical Trials Clinical Trials 130

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

HR 130

HR FDA Approval Licensing Licensing 130

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.

HR 98

HR Antibody Hormones Drugs 98

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. Its safety and efficacy have not been established for this indication.

HR 52

HR Hormones Medicine Trials 52

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. Accelerated approvals are granted based on earlier trial data, with the expectation that manufacturers will supply full efficacy and safety data from a larger trial.

Trials 83

Trials HR Drugs Sales 83

pharmaphorum

APRIL 25, 2022

Roche revealed in its first-quarter results statement that giredestrant missed the mark in the phase 2 acelERA trial in advanced breast cancer, in what appears to be another blow to the emerging oral selective oestrogen receptor degrader (SERD) class.

Trials 69

Trials Hormones HR Sales 69

The Pharma Data

FEBRUARY 21, 2022

Enhertu is a HER2-directed antibody drug conjugate (ADC) being jointly developed by AstraZeneca and Daiichi Sankyo. All patients in the trial received a HER2 test, and the results were centrally confirmed. 1,2 HER2-low expression occurs in both HR-positive and HR-negative disease.3.

HR 52

HR Trials Hormones Antibody 52

pharmaphorum

AUGUST 15, 2022

In the space of a couple of months, Gilead Sciences’ Trodelvy impact on overall survival (OS) in the TROPICs-02 trial in advanced breast cancer has gone from a trend to a statistically significant improvement, raising its chances of approval in a new indication.

HR 90

HR Hormones Sales Antibody 90

The Pharma Data

DECEMBER 29, 2020

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. Regeneron Pharmaceuticals, Inc. futility analysis). log 10 copies/mL for combined doses).

Antibody 52

Antibody Trials Production Clinical Trials 52

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.

HR 98

HR FDA Approval Gene Trials 98

pharmaphorum

FEBRUARY 14, 2022

Astellas and Seagen’s Padcev is on course to move further up the treatment pathway in bladder cancer, thanks to a positive readout in the EV-103 clinical trial. For that reason, Seagen and Astellas are running phase 3 trials of Padcev in combination with Keytruda, in the hope showing synergy between the two treatments.

Trials 59

Trials Drugs HR Sales 59

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.

HR 52

HR Trials Protein Medicine 52

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

HR 52

HR Hormones FDA Approval Antibody 52

Trialfacts

SEPTEMBER 15, 2024

VIKTORIA-1 is a clinical trial aimed at evaluating gedatolisib, a new investigational drug for patients with HR+/HER2-, Stage 3 or 4 breast cancer. This trial explores the potential of gedatolisib, given intravenously, to inhibit the PI3K/mTOR pathway, which is known to regulate cell growth and function.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Genetics 52

The Pharma Data

MARCH 15, 2021

Trial enrolled patients with advanced cervical cancer regardless of PD-L1 status. The trial will be stopped early based on a unanimous recommendation by the Independent Data Monitoring Committee (IDMC), and the data will form the basis of regulatory submissions in 2021. This is reflected in the trial where the average age was 51.”.

Trials 52

Trials HR Genetics Medicine 52

pharmaphorum

SEPTEMBER 9, 2022

Prospects for Gilead Sciences’ Trodelvy in hormone receptor-positive, HER2-negative metastatic breast cancer continue to improve as data from the TROPiCs-02 trial strengthen, but the jury is still out on what that might mean for the drug commercially.

HR 52

HR Hormones Trials Sales 52

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. 1 The approval is based on the Phase 2/3 RELATIVITY-047 trial, which compared Opdualag (n=355) to nivolumab alone (n=359).1,2 to 5.6); (Hazard Ratio [HR] 0.75; 95% CI: 0.62

Antibody 52

Antibody HR Trials Dermatology 52

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.

HR 52

HR Hormones Trials Drugs 52

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.

HR 52

HR Sales Antibody Hormones 52

The Pharma Data

JANUARY 14, 2021

(NASDAQ: FPRX) today announced clinical results from the global, randomized, double-blind placebo-controlled Phase 2 FIGHT trial evaluating first-in-class targeted therapy bemarituzumab in advanced gastric or gastroesophageal junction (GEJ) cancer. Phase 2 FIGHT Trial: Summary of Efficacy*. HR (95% CI): 0.68.

Trials 52

Trials HR Containment Development 52

XTalks

DECEMBER 4, 2020

Ajay Srivastava, Senior Medical Director, Medical Department, and Carrie Sheil, Senior Director, Clinical Trial Management, both from Medpace, shared changes to the CKD treatment paradigm and offered advice on optimizing study design for CKD trials. GFR also forms a basis of eligibility requirements for clinical trials.

Trials 52

Trials Clinical Trials Clinical Trials Antibody 52

XTalks

FEBRUARY 5, 2024

PD-1 checkpoint inhibitors like Opdivo and Keytruda have been transformative in oncology, with Keytruda having had the edge due to having approvals in several more indications than Opdivo and strong clinical trial results, including as a first-line treatment in combination with chemotherapy. percent from 2021 to 2022 for Janssen.

FDA Approval 101

FDA Approval Drugs Sales Development 101

The Pharma Data

AUGUST 9, 2021

Positive high-level results from the head-to-head DESTINY-Breast03 Phase III trial showed that Enhertu (trastuzumab deruxtecan), the AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) HER2-directed antibody drug conjugate (ADC), demonstrated superiority over trastuzumab emtansine (T-DM1).

Trials 52

Trials Medicine Development Clinical Trials 52

The Pharma Data

SEPTEMBER 28, 2021

Data from the IMpower010 trial were published simultaneously within the Lancet. Data from the IMpower010 trial were published simultaneously within the Lancet. In IMpower010, treatment with Tecentriq, following surgery and chemotherapy, reduced the danger of disease recurrence or death (DFS) by 34% (hazard ratio [HR]=0.66, 95% CI: 0.50–0.88)

Clinical Trials 52

Clinical Trials Clinical Trials Trials HR 52

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.

HR 72

HR Medicine Drugs Licensing 72

The Pharma Data

APRIL 26, 2022

STRIDE regimen of a single priming dose of tremelimumab added to Imfinzi is the first dual immune checkpoint blockade regimen to improve overall survival in a Phase III trial in this setting. The trial was conducted in 181 centres across 16 countries, including in the US, Canada, Europe, South America and Asia. 0.93; p=0.0035).4

Immune Response 52

Immune Response Trials Protein Antibody 52

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 Continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial.

HR 52

HR Trials Containment Development 52

The Pharma Data

SEPTEMBER 10, 2021

POSEIDON Phase III trial showed the addition of a short course of tremelimumab to Imfinzi plus chemotherapy improved patient outcomes without an increase in treatment discontinuation. This treatment combination also reduced the risk of disease progression or death by 28% compared to chemotherapy alone (HR 0.72; 95% CI 0.60-0.86;

HR 52

HR Trials Medicine Immune Response 52

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]; As previously announced , the trial will continue to evaluate OS, a key secondary endpoint. KENILWORTH, N.J.–(BUSINESS months (14.9-41.5),

HR 52

HR Trials Clinical Research Research 52

The Pharma Data

MARCH 17, 2021

This approval is based on results from the pivotal Phase 3 KEYNOTE-204 trial, in which KEYTRUDA monotherapy demonstrated a significant improvement in progression-free survival (PFS) compared with brentuximab vedotin (BV), a commonly used treatment. KEYTRUDA reduced the risk of disease progression or death by 35% (HR=0.65 [95% CI, 0.48-0.88];

HR 52

HR Trials Antibody Clinical Research 52

The Pharma Data

MARCH 2, 2021

Study 20120215 is a Phase 3 open-label, multicenter, randomized, controlled trial evaluating event-free survival after treatment with BLINCYTO compared with standard of care consolidation chemotherapy in pediatric patients with high-risk first-relapse B-cell ALL. Click here to read about the trial on ClinicalTrials.gov.

HR 52

HR Trials Antibody Development 52

The Pharma Data

JUNE 26, 2021

Approval based on a Phase 3 trial demonstrating Libtayo significantly improved overall survival compared to chemotherapy in advanced NSCLC that included challenging-to-treat patient populations Libtayo now approved by the European Commission for three advanced cancers. 0.87; p=0.0022).

Trials 52

Trials Genetics Antibody HR 52

The Pharma Data

JUNE 29, 2021

This approval is based on results from the Phase 3 KEYNOTE-590 trial, in which KEYTRUDA plus 5-fluorouracil (5-FU) and cisplatin demonstrated statistically significant improvements in overall survival (OS) and progression-free survival (PFS) compared with 5-FU and cisplatin alone in all pre-specified study populations.

HR 52

HR Clinical Research Trials Research 52

The Pharma Data

JULY 15, 2021

The trial investigated neoadjuvant KEYTRUDA, Merck’s anti-PD-1 therapy, plus chemotherapy followed by adjuvant KEYTRUDA as monotherapy (the KEYTRUDA regimen) compared with neoadjuvant chemotherapy followed by adjuvant placebo (the chemotherapy-placebo regimen) in patients with high-risk early-stage triple-negative breast cancer (TNBC).

HR 52

HR Trials Clinical Development Clinical Research 52

The Pharma Data

SEPTEMBER 16, 2020

Blueprint Medicines will present new data from the registrational phase I/II ARROW trial, investigating Gavreto TM (pralsetinib) for the treatment of people with RET-mutant medullary thyroid cancer. New integrated analyses from our tumour agnostic Rozlytrek ® (entrectinib) clinical development programme.

HR 52

HR Medicine Hormones Trials 52

The Pharma Data

JANUARY 15, 2021

In the DESTINY-Gastric01 trial, patients (n=126) in the Enhertu treatment arm had a 41% reduction in the risk of death versus patients (n=62) treated with chemotherapy (based on a hazard ratio [HR] of 0.59; 95% confidence interval [CI] 0.39-0.88; 4.3] (HR=0.47; 95% CI 0.31-0.71) Regular approval by the U.S. months [95% CI 9.6-14.3]

Medicine 52

Medicine Trials Antibody HR 52

The Pharma Data

NOVEMBER 18, 2021

The blessing is grounded on data from the vital Phase 3 KEYNOTE-564 trial, in which KEYTRUDA demonstrated a statistically significant enhancement in complaint-free survival (DFS), reducing the threat of complaint rush or death by 32 (HR = 0.68 (95 CI,0.53-0.87); 0.87); p = 0.0010) compared to placebo. 0.87); p = 0.0010). About Merck.

FDA Approval 52

FDA Approval HR Trials Drugs 52