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

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 91

HR Antibody Hormones Drugs 91

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

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 76

Trials HR Drugs Sales 76

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

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

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

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 66

HR Hormones Sales Antibody 66

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

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

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 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 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

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

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.

Life Science 110

Life Science Development Marketing Gene Expression 110

XTalks

MAY 2, 2024

Karuna’s FDA submission, made in September 2023, included data from one Phase II and two Phase III placebo-controlled trials. In the Phase III EMERGENT-3 trial, compared to placebo, KarXT led to a 9.6-point Karuna also has ongoing long-term extension trials. It is also entering late into the market.

Drugs 52

Drugs FDA Approval Sales Vaccination 52

The Pharma Data

APRIL 8, 2021

The trial did not meet statistical significance on the primary endpoint, which was defined as a difference in the proportion of participants progressing to the first occurrence of non-invasive ventilation including high flow oxygen or invasive mechanical ventilation including extracorporeal membrane oxygenation (ECMO) or death by Day 28.

FDA Approval 52

FDA Approval HR Trials Medicine 52

The Pharma Data

AUGUST 3, 2021

The study showed that treatment with Tecentriq, following surgery and platinum-based chemotherapy, reduced the risk of disease recurrence or death (DFS) by 34% (hazard ratio [HR]=0.66, 95% CI: 0.50-0.88) Results from the IMpower010 trial were presented at the 2021 ASCO Annual Meeting. 1%, compared with best supportive care (BSC).

HR 52

HR Antibody FDA Approval Development 52

The Pharma Data

AUGUST 3, 2021

announced today results from an additional cohort of 101 adult patients from the COV-BARRIER trial. Similar mortality benefit was observed by Day 60 (HR [96% CI] = 0.56 [0.33, 0.97]) with a cumulative proportion of death of 45.1 In the COVID-19 clinical trials, adverse drug reactions in the safety population occurring in ?

HR 52

HR Licensing Licensing FDA Approval 52

The Pharma Data

JULY 29, 2021

Data supporting the initial EUA included the primary endpoint of median time to recovery, which was seven days for baricitinib plus remdesivir compared to eight days for placebo plus remdesivir (HR: 1.15; 95% CI: 1.00, 1.31; p=0.047). In the COVID-19 clinical trials, adverse drug reactions in the safety population occurring in ?

HR 52

HR Licensing Licensing FDA Approval 52

XTalks

DECEMBER 19, 2023

The EPIC-HR clinical study that showed reduced risk of hospitalization or death with Paxlovid use prompted the National Institutes of Health (NIH) to prioritize it over other COVID-19 treatments. In a particular trial, 29 percent of patients experienced a partial or complete reduction in their tumor burden, with an average duration of 7.4

Sales 64

Sales FDA Approval Drugs Vaccination 64

The Pharma Data

APRIL 23, 2021

Results of the VIALE-A study showed Venclyxto plus azacitidine significantly reduced the risk of death by 34% (overall survival; OS), compared to azacitidine alone (HR=0.66; 95% CI: 0.52, 0.85; p<0.001). The median OS was 14.7 months (95% CI: 11.9, in the Venclyxto group and 9.6 months (95% CI: 7.4, in the control group.

Medicine 40

Medicine In-Vitro Antibody Development 40

Pfizer

JANUARY 27, 2023

This research provides a way for us to rapidly assess the ability of an existing vaccine to induce antibodies that neutralize a newly identified variant of concern. This work is undertaken once a new variant of concern has been identified by public health authorities. No dosage adjustment is needed in patients with mild renal impairment.

Research 112

Research Vaccination Vaccine Drugs 112

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

JUNE 18, 2021

The study met its primary endpoint of superior progression-free survival (PFS) as assessed by an independent review committee (IRC) with a HR 0.216 (95% CI, 0.131-0.357; p < 0.0001), demonstrating a reduction in the risk of disease progression or death for I+V of approximately 78% compared to C+O. vs. 11.4%) (p < 0.0001).

Medicine 52

Medicine Production FDA Approval Trials 52

XTalks

AUGUST 2, 2023

5) Ibrance (palbociclib) Ibrance is a chemotherapy drug indicated for hormone receptor positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer. The monoclonal antibody targets CD20, a protein found on the surface of B lymphocytes (B cells). The list price of Stelara was stated to be $25,497.12

Sales 98

Sales Manufacturing FDA Approval Life Science 98

The Pharma Data

JUNE 18, 2021

lead study investigator of the Phase 3 RESONATE-2 trial, and Professor of Medicine at the Wilmot Cancer Institute, University of Rochester. 1 With up to seven years of follow-up, progression-free survival (PFS) benefit with single-agent IMBRUVICA was sustained (Hazard Ratio [HR] 0.160 [95 percent Confidence Interval (CI): 0.111–0.230]).

FDA Approval 40

FDA Approval Medicine Development Trials 40