Targeted Therapy for Advanced Stage Cancer

(TAPUR Trial)

Recruiting at 193 trial locations

Overseen By Jacqueline Perez, MPH

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: American Society of Clinical Oncology

Must be taking: Targeted therapies

Disqualifiers: Primary brain tumors, Leptomeningeal metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

4200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores targeted therapies for individuals with advanced cancer whose tumors have specific genetic changes that might respond to certain drugs. Each participant receives treatment based on their tumor's genetic makeup, such as abemaciclib (a CDK4/6 inhibitor) for those with specific CDK gene mutations or entrectinib for tumors with ROS1 fusions. Suitable candidates have stopped benefiting from standard treatments and have measurable disease, meaning their cancer can be seen or measured on scans. The goal is to assess how well these treatments work in real-world settings for different genetic profiles. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with your doctor or the trial coordinators.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found nivolumab and ipilimumab effective and generally well-tolerated for treating advanced melanoma. However, some patients experienced serious side effects, such as tiredness and skin rash, with about 58.5% having severe side effects. Research on temsirolimus has shown it is usually well-tolerated, though side effects like tiredness, nausea, or mouth sores can occur.

Entrectinib is another treatment option, effective for patients with a specific type of cancer involving the ROS1 gene. Common side effects include tiredness and dizziness. Lastly, abemaciclib is approved for breast cancer treatment and is often well-tolerated, with side effects like diarrhea and tiredness.

Each treatment has its own set of possible side effects. It is important to talk with healthcare providers to understand what to expect. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these cancer treatments because they target specific genetic mutations, offering personalized therapy. Unlike traditional chemotherapy, which attacks all rapidly dividing cells, these treatments focus on particular mutations like ROS1 fusions, NTRK amplifications, or BRCA1/2 mutations, enhancing effectiveness and reducing side effects. For instance, larotrectinib uniquely targets NTRK fusions, while futibatinib focuses on FGFR fusions or mutations. This precision approach not only promises better outcomes but also opens new avenues for treating cancers previously considered untreatable with standard options.

What evidence suggests that this trial's treatments could be effective for advanced cancer?

In this trial, researchers will assign participants to different treatment groups based on specific genetic changes. Nivolumab and ipilimumab, which participants in Group 16 may receive, demonstrated a five-year survival rate of 52% for some cancers in previous studies. Participants in Group 6 will receive temsirolimus, which research has shown can help with certain cancers by targeting genetic changes in the mTOR pathway. Entrectinib, administered to participants in Group 22, proved effective for cancers with ROS1 fusion, with a response rate of 81.5%. Abemaciclib, which participants in Group 17 may receive, significantly extended survival in breast cancer patients, especially those with certain genetic markers. Talazoparib, given to participants in Group 19, showed good results, particularly for those with BRCA mutations. Trastuzumab and pertuzumab, administered to participants in Group 8, improved survival and response in HER2-positive cancers. Each of these treatments targets specific genetic changes, making them promising options for advanced cancer cases. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for people aged 12+ with advanced cancer, such as solid tumors, multiple myeloma or B cell non-Hodgkin lymphoma. Participants must be able to take oral medication, agree to use contraception, and have a specific abnormality in their tumor genes that can be targeted by the study drugs.

Inclusion Criteria

I have an advanced or spreading cancer, multiple myeloma, or B cell lymphoma.

I can swallow and tolerate pills.

I have results from a genetic or protein test for my cancer.

Exclusion Criteria

My cancer can't be measured or found through scans or exams.

I have a primary brain tumor or cancer that has spread to the lining of my brain.

I have had brain metastases, but no seizures or major changes in my neurological status in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive FDA-approved targeted therapies based on genomic variants for 16 weeks

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Abemaciclib
• Afatinib
• Atezolizumab and PHESGO
• Atezolizumab and Talazoparib
• Crizotinib
• Entrectinib
• Futibatinib
• Larotrectinib
• Nivolumab and Ipilimumab
• Olaparib
• Palbociclib
• Pembrolizumab
• Regorafenib
• Sunitinib
• Talazoparib
• Temsirolimus
• Trastuzumab and Pertuzumab
• Tucatinib plus Trastuzumab Subcutaneous (SC)
• Vemurafenib and Cobimetinib

Trial Overview The TAPUR study tests FDA-approved drugs targeting specific genetic abnormalities in tumors. It aims to learn how these therapies work in real-world settings for patients with advanced stage cancers who show sensitivity to these drugs based on genomic testing.

How Is the Trial Designed?

Group I: Group 9 (BRAF V600E/D/K/R) Experimental Treatment 1 Intervention

Participants receive vemurafenib and cobimetinib - dosage, frequency and duration per label; acceptable genomic matches include BRAF V600E/D/K/R mutations

Group II: Group 8 (ERBB2) Experimental Treatment 1 Intervention

Participants receive trastuzumab and pertuzumab - dosage, frequency and duration per label; acceptable genomic matches include ERBB2 amplification or overexpression, and specific ERBB2 mutations

Group III: Group 6 (mTOR, TSC) Experimental Treatment 1 Intervention

Participants receive temsirolimus - dosage, frequency and duration per label; acceptable genomic matches include mTOR, TSC1/2, AKT1 mutations

Group IV: Group 5 (CSF1R,PDGFR,VEGFR) Experimental Treatment 1 Intervention

Participants receive sunitinib - dosage, frequency and duration per label; acceptable genomic matches include CSF1R, PDGFR, VEGFR1/2/3, KIT, FLT-3, RET, FGFR1/2/3, VHL amplifications or mutations

Group V: Group 4 (CDKN2A, CDK4, CDK6) Experimental Treatment 1 Intervention

Participants receive palbociclib - dosage, frequency and duration per label; acceptable genomic matches include CDKN2A loss or mutation, CDK4, CDK6 amplifications, CDKN2B loss or mutation

Group VI: Group 25 Experimental Treatment 1 Intervention

Participants receive futibatinib- dosage, frequency and duration per label; acceptable genomic matches include FGFR 1,2,3,4 fusion (or other rearrangement) or mutation

Group VII: Group 24 (ERBB2) Experimental Treatment 1 Intervention

Participants receive tucatinib plus trastuzumab SC - dosage, frequency and duration per label; acceptable genomic matches include ERBB2 amplification or overexpression, and specific ERBB2 mutations

Group VIII: Group 23 (NTRK amplification) Experimental Treatment 1 Intervention

Participants receive larotrectinib - dosage, frequency and duration per label; acceptable genomic matches include NTRK1/2/3 amplification

Group IX: Group 22 (ROS1 fusion) Experimental Treatment 1 Intervention

Participants receive entrectinib - dosage, frequency and duration per label; acceptable genomic matches include any ROS1 fusion

Group X: Group 21 (BRCA1/2, PALB2, ATM, and others) Experimental Treatment 1 Intervention

Participants receive atezolizumab plus talazoparib - dosage, frequency and duration per label; acceptable genomic matches include germline or somatic mutations in BRCA1/2, PALB2, ATM, ATR, CHEK2, FANCA, RAD51C, NBN, MLH1, MRE11A, CDK12; positive genomic instability score reported on the Myriad MyChoice CDx test; or Genomic Loss of Heterozygosity (LOH) Score above threshold as reported on a FoundationOne CDx test or another qualifying test for TAPUR with MTB approval

Group XI: Group 20 (ERBB2) Experimental Treatment 1 Intervention

Participants receive atezolizumab plus PHESGO - dosage, frequency and duration per label; acceptable genomic matches include ERBB2 amplification or overexpression

Group XII: Group 19 (BRCA1/2, PALB2) Experimental Treatment 1 Intervention

Participants receive talazoparib - dosage, frequency and duration per label; acceptable genomic matches include germline or somatic BRCA1/2 and PALB2 mutations

Group XIII: Group 17 (CDKN2A, CDK4, CDK6) Experimental Treatment 1 Intervention

Participants receive abemaciclib - dosage, frequency and duration per label; acceptable genomic matches include CDKN2A loss or mutation, CDK4, CDK6 amplifications, CDKN2B loss or mutation

Group XIV: Group 16 (MSI-H, high mutational load and others) Experimental Treatment 1 Intervention

Participants receive nivolumab and ipilimumab - dosage, frequency and duration per label; acceptable genomic matches include MSI high status, high tumor mutational burden, MLH1, MSH2/6, PMS2, EPCAM mutations, specific POLE or POLD1 mutations, BRCA1/2, ATM, MSH3, PMS1, MLH3, EXO1, RFC1/2/3/4/5, PCNA, RPA1/2/3/4, and SSBP1 loss of function mutations

Group XV: Group 15 (POLE, POLD1) Experimental Treatment 1 Intervention

Participants receive pembrolizumab - dosage, frequency and duration per label; acceptable genomic matches include specific POLE and POLD1 mutations

Group XVI: Group 14 (BRCA1/2; ATM) Experimental Treatment 1 Intervention

Participants receive olaparib - dosage, frequency and duration per label; acceptable genomic matches include germline or somatic BRCA1/2 inactivating mutations; ATM mutations or deletions

Group XVII: Group 13 (RET,VEGFR1/2/3,KIT,PDGFRβ,RAF-1,BRAF) Experimental Treatment 1 Intervention

Participants receive regorafenib - dosage, frequency and duration per label; acceptable genomic matches include RET, VEGFR1/2/3, KIT, PDGFRβ, RAF-1, BRAF mutations or amplifications

Abemaciclib is already approved in United States, European Union for the following indications:

Approved in United States as Verzenio for:

• Hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
• HR+, HER2- node-positive early breast cancer

Approved in European Union as Verzenio for:

• HR+, HER2- advanced or metastatic breast cancer
• HR+, HER2- node-positive early breast cancer

Who Is Running the Clinical Trial?

American Society of Clinical Oncology

Lead Sponsor

Trials

40

Recruited

148,000+

AstraZeneca

Industry Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Bayer

Industry Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

Known For

Pharmaceutical Innovations

Top Products

Aspirin, Aleve, Yaz, Nexavar

Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Eli Lilly and Company

Industry Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Genentech, Inc.

Industry Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Boehringer Ingelheim

Industry Sponsor

Trials

2,566

Recruited

16,150,000+

Seagen Inc.

Industry Sponsor

Trials

212

Recruited

73,800+

Founded

1997

Headquarters

Bothell, USA

Known For

Antibody-Drug Conjugates

Top Products

Adcetris (brentuximab vedotin), Tukysa (tucatinib), Padcev (enfortumab vedotin-ejfv), Tivdak (tisotumab vedotin-tftv)

Dr. Roger Dansey

Seagen Inc.

Chief Medical Officer since 2018

MD from University of Witwatersrand

David R. Epstein

Seagen Inc.

Chief Executive Officer since 2022

BSc in Pharmacy from Rutgers University, MBA from Columbia University

Taiho Oncology, Inc.

Industry Sponsor

Trials

79

Recruited

12,700+

Tim Whitten

Taiho Oncology, Inc.

Chief Executive Officer since 2018

MBA and Pharmacy degree

Harold Keer

Taiho Oncology, Inc.

Chief Medical Officer

MD, PhD

Published Research Related to This Trial

In a subanalysis of the KEYNOTE-024 study involving 40 Japanese patients with untreated metastatic non-small-cell lung cancer, pembrolizumab significantly improved progression-free survival (HR 0.25) and overall survival (HR 0.39) compared to chemotherapy.

Both treatment groups experienced high rates of treatment-related adverse events (100% for pembrolizumab and 95% for chemotherapy), but the safety profile was manageable, with a notable occurrence of immune-mediated adverse events in 52% of pembrolizumab patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-line pembrolizumab vs chemotherapy in metastatic non-small-cell lung cancer: KEYNOTE-024 Japan subset. Satouchi, M., Nosaki, K., Takahashi, T., et al.[2021]

In a phase 1b study involving 50 patients with advanced non-small cell lung cancer (NSCLC), the combination of abemaciclib and pembrolizumab showed significant toxicity, with 80% of patients in cohort A and 76% in cohort B experiencing severe treatment-emergent adverse events.

Despite some antitumor activity, including a disease control rate of 56% in cohort A and 64% in cohort B, the overall risk-benefit profile of this combination therapy does not support further investigation in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abemaciclib in Combination With Pembrolizumab for Stage IV KRAS-Mutant or Squamous NSCLC: A Phase 1b Study. Pujol, JL., Vansteenkiste, J., Paz-Ares Rodríguez, L., et al.[2022]

Atezolizumab, an anti-PD-L1 therapy, was well tolerated in a study of 45 patients with advanced melanoma, showing that most side effects were mild (grade 1/2) and no treatment-related deaths occurred.

The treatment resulted in a 30% overall response rate and a median overall survival of 23 months, with certain biomarkers like PD-L1 expression and tumor mutational burden linked to better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, Clinical Activity, and Biological Correlates of Response in Patients with Metastatic Melanoma: Results from a Phase I Trial of Atezolizumab. Hamid, O., Molinero, L., Bolen, CR., et al.[2020]

Interim results from the MONARCH3 study show that abemaciclib, a CDK4/6 inhibitor, is an effective first-line treatment for advanced ER-positive, HER2-negative breast cancer.

Patients receiving abemaciclib in combination with letrozole experienced significantly improved progression-free survival compared to those receiving a placebo with endocrine therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-Line Abemaciclib Effective in ER+ Breast Cancer. [2019]

In a retrospective study of 69 female patients with hormone receptor-positive, HER2-negative metastatic breast cancer, abemaciclib demonstrated effectiveness as both a monotherapy and in combination with endocrine therapy, aligning with previous clinical trial results.

The median duration of abemaciclib treatment was 7.7 months, with 86% of patients discontinuing treatment mainly due to disease progression, indicating that while effective, the drug is often used in heavily pretreated patients with advanced disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Observational study of HR+/HER2- metastatic breast cancer patients treated with abemaciclib in Spain in the Named Patient Use Program (AbemusS). Blanch, S., Gil-Gil, JM., Arumí, M., et al.[2023]

In a subanalysis of the KEYNOTE-024 study involving 40 patients in Japan, pembrolizumab significantly improved median progression-free survival to 41.4 months compared to just 4.1 months with chemotherapy, indicating its superior efficacy in treating metastatic non-small-cell lung cancer.

Both treatments had high rates of treatment-related adverse events (100% for pembrolizumab and 95% for chemotherapy), but pembrolizumab was associated with a higher incidence of immune-mediated adverse events, suggesting that while it is effective, monitoring for side effects is crucial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-line pembrolizumab vs chemotherapy in metastatic non-small-cell lung cancer: KEYNOTE-024 Japan subset. Satouchi, M., Nosaki, K., Takahashi, T., et al.[2022]

Abemaciclib combined with endocrine therapy (ET) significantly improves quality-adjusted life years (QALYs) in patients with high-risk hormone receptor positive, HER2-negative early breast cancer, with an increase of 0.99 QALYs compared to ET alone.

The treatment is considered cost-effective in Italy, with an incremental cost-effectiveness ratio of €22,651 per QALY gained, and a 99% likelihood of being cost-effective at a threshold of €30,000 per QALY.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness analysis of abemaciclib with endocrine therapy (ET) versus ET alone for HR+, HER2-, node-positive, high-risk early breast cancer in Italy. Davie, A., Traoré, S., Giovannitti, M., et al.[2023]

In a study involving 495 patients with advanced BRAF(V600)-mutant melanoma, the combination of cobimetinib and vemurafenib significantly improved median progression-free survival to 12.3 months compared to 7.2 months for the placebo group, indicating a strong efficacy of the treatment.

The combination therapy also resulted in a median overall survival of 22.3 months versus 17.4 months for the placebo group, with a manageable safety profile and no new safety concerns identified during the extended follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cobimetinib combined with vemurafenib in advanced BRAF(V600)-mutant melanoma (coBRIM): updated efficacy results from a randomised, double-blind, phase 3 trial. Ascierto, PA., McArthur, GA., Dréno, B., et al.[2022]

In the phase III MONARCH 2 study, abemaciclib combined with fulvestrant significantly improved progression-free survival (PFS) in patients with hormone receptor-positive, HER2-negative advanced breast cancer, while also maintaining health-related quality of life (HRQoL) scores throughout treatment.

Patients receiving abemaciclib experienced a 4.9-month delay in pain deterioration and better overall functioning compared to those on placebo, indicating that this treatment not only extends survival but also enhances the quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health-Related Quality of Life in MONARCH 2: Abemaciclib plus Fulvestrant in Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer After Endocrine Therapy. Kaufman, PA., Toi, M., Neven, P., et al.[2022]

In a phase 2 study involving 65 patients with BRAFV600 mutation-positive melanoma and CNS metastases, the combination of atezolizumab with vemurafenib and cobimetinib showed a promising intracranial objective response rate of 42%.

The treatment was associated with significant adverse events, with 68% of patients experiencing grade 3 or worse side effects, highlighting the need for careful monitoring during therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab, vemurafenib, and cobimetinib in patients with melanoma with CNS metastases (TRICOTEL): a multicentre, open-label, single-arm, phase 2 study. Dummer, R., Queirolo, P., Abajo Guijarro, AM., et al.[2023]

The combination of encorafenib (ENC) and binimetinib (BIN) was found to be cost-effective compared to cobimetinib (COB) and vemurafenib (VEM) only at a very high willingness-to-pay threshold of $573,000 per quality-adjusted life year (QALY).

The combination of dabrafenib (DAB) and trametinib (TRA) was determined to be the most optimal treatment option for BRAF-mutated advanced melanoma, dominating the COB + VEM combination in terms of cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Economic Evaluation of Three BRAF + MEK Inhibitors for the Treatment of Advanced Unresectable Melanoma With BRAF Mutation From a US Payer Perspective. Halloush, S., Alkhatib, NS., Almutairi, AR., et al.[2023]

Pembrolizumab was approved by the FDA for treating patients with high tumor mutational burden (TMB-H) solid tumors, showing a 29% overall response rate and 57% of responses lasting over 12 months in a trial with 102 patients.

This approval marks a significant milestone as it is the first cancer treatment approved based on TMB, highlighting the importance of genetic markers in cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Pembrolizumab for the Treatment of Tumor Mutational Burden-High Solid Tumors. Marcus, L., Fashoyin-Aje, LA., Donoghue, M., et al.[2022]

The combination of nintedanib (150 mg bid) and pembrolizumab was found to be safe, with a maximum tolerated dose established and only a few patients experiencing significant side effects, such as grade 3 liver enzyme increases.

In this study of 13 patients, 25% achieved a partial response to treatment, and 42% had a durable clinical benefit, indicating that early immune and angiogenic markers may help predict treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, recommended dose, efficacy and immune correlates for nintedanib in combination with pembrolizumab in patients with advanced cancers. Baldini, C., Danlos, FX., Varga, A., et al.[2022]

In a long-term study of 123 patients with advanced nonsquamous NSCLC, the combination of pembrolizumab with pemetrexed-carboplatin significantly improved the objective response rate (58% vs. 33%) and progression-free survival (24.5 months vs. 9.9 months) compared to chemotherapy alone.

Patients who completed 2 years of pembrolizumab treatment had a remarkable 92% survival rate at the data cutoff, indicating a durable clinical benefit, while the safety profile remained manageable with no new safety concerns identified.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Overall Survival From KEYNOTE-021 Cohort G: Pemetrexed and Carboplatin With or Without Pembrolizumab as First-Line Therapy for Advanced Nonsquamous NSCLC. Awad, MM., Gadgeel, SM., Borghaei, H., et al.[2021]

In a phase 2 study involving 65 patients with BRAFV600 mutation-positive melanoma, the combination of atezolizumab, vemurafenib, and cobimetinib showed a significant intracranial objective response rate of 42%, indicating its efficacy in treating CNS metastases.

The treatment was associated with a high incidence of grade 3 or worse adverse events (68% in the BRAFV600 mutation-positive cohort), but no treatment-related deaths were reported, suggesting that while the therapy is effective, it carries a risk of serious side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab, vemurafenib, and cobimetinib in patients with melanoma with CNS metastases (TRICOTEL): a multicentre, open-label, single-arm, phase 2 study. Dummer, R., Queirolo, P., Gerard Duhard, P., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT01394016

NCT01394016 | A Phase 1 Study of LY2835219 In ... The purpose of this study is to determine a safe dose of Abemaciclib to be given to participants with advanced cancer and to determine any side effects that ...

2. prnewswire.com prnewswire.com/news-releases/lillys-verzenio-abemaciclib-prolonged-survival-in-hr-her2--high-risk-early-breast-cancer-with-two-years-of-treatment-302586849.html

Lilly's Verzenio® (abemaciclib) prolonged survival in HR+, ... Verzenio is the first contemporary therapy in over two decades to demonstrate a significant overall survival benefit in adjuvant HR+, HER2−, ...

3. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK601722/

Clinical Review - Abemaciclib (Verzenio) - NCBI Bookshelf - NIH Based on data from the monarchE trial, abemaciclib plus ET demonstrated a statistically significant and clinically meaningful benefit compared to ET ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0960977625006149

Metastatic Breast Cancer: A Propensity-Matched ... In this large, real-world cohort study, first-line abemaciclib was associated with a significant overall survival benefit compared to ...

5. oncpracticemanagement.com oncpracticemanagement.com/special-issues/the-evolution-of-abemaciclib-clinical-trial-data-for-the-treatment-of-hr-positive-her2-negative-metastatic-breast-cancer

The Evolution of Abemaciclib Clinical Trial Data for ... This article offers an overview of abemaciclib, clinical data in HR-positive/HER-negative metastatic breast cancer treatment, optimal administration, and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7990838/

Safety and efficacy of abemaciclib plus endocrine therapy ... Abemaciclib in combination with endocrine therapy (ET) has demonstrated significant efficacy benefits in HR+ , HER2− advanced breast cancer patients.

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2017/208716Orig1s000RiskR.pdf

208716Orig1s000 - accessdata.fda.gov The efficacy and safety of abemaciclib for the treatment of HR+, HER2- advanced or metastatic breast cancer was demonstrated in two pivotal ...

8. ascopubs.org ascopubs.org/doi/10.1200/JCO-24-02086

Abemaciclib Plus Fulvestrant in Advanced Breast Cancer ... OS data were immature at the time of data cutoff, with 40 deaths (22%) in the abemaciclib + fulvestrant arm and 37 deaths (20%) in the placebo + ...