Phase 2 Study of Paclitaxel (NSC #673089) + Ipatasertib (NSC #781451) in Taxane-Refractory Participants With PTEN/AKT-Altered Advanced Non-Breast Solid Tumors: A ComboMATCH Treatment Trial

This phase II ComboMATCH treatment trial tests the usual treatment of chemotherapy (paclitaxel) plus ipatasertib in patients with solid tumor cancers that that cannot be removed by surgery (unresectable), has spread to nearby tissue or lymph nodes (locally advanced) or from where it first started (primary site) to other places in the body (metastatic), and has PTEN and AKT genetic changes. Chemotherapy drugs, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Targeted therapy, such as Ipatasertib, may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The addition of ipatasertib to paclitaxel in solid tumors with PTEN and AKT genetic changes could increase the percentage of tumors that shrink as well as lengthen the time that the tumors remain stable (without progression). Researchers hope to learn if paclitaxel plus ipatasertib will shrink this type of cancer or stop its growth.

Start Date22 Sep 2023

Sponsor / Collaborator

National Cancer Institute

NCT05332561 / RecruitingPhase 2IIT

Genomics Guided Targeted Post-neoadjuvant Therapy in Patients With Early Breast Cancer - a Multicenter, Open-label, Umbrella Phase-II Study - COGNITION-GUIDE

In early breast cancer (eBC), pathological complete response (pCR) after neoadjuvant therapy acts as surrogate marker for metastasis and overall survival. Therapy intensification by adding an adjuvant therapy line (post-neoadjuvant treatment) substantially lowers the risk of relapse in high-risk breast cancer patients with residual disease after neoadjuvant treatment (non-pCR). While this approach was exemplified in two phase III trials without biomarker-stratification (CREATE-X, KATHERINE), even higher efficiency might be achieved by individualized genomic-guided post-neoadjuvant therapies.
Within the seven-arm umbrella phase-II clinical trial COGNITION-GUIDE, we aim to deliver molecularly-tailored cancer care by implementing an additional response- and genomics-guided post-neoadjuvant therapy after finishing the guideline-compliant post-neoadjuvant treatment in high-risk breast cancer patients with residual cancer burden after neoadjuvant therapy to reduce the substantial risk of local and distant relapse.
The trial evaluates not a single drug but rather a general strategy of precision oncology in the curative setting and provides the basis for future confirmatory biomarker-driven trials.
Allocation to the therapy-arms is conducted by in depth molecular characterization of tumors within the COGNITION registry program.
The study aims to show an overall benefit of the precision medicine approach in high-risk eBC patients and to allow for secondary exploratory evaluation of each study-arm.
The primary endpoint of the study is invasive Disease-Free Survival (IDFS) after 4 years measured from surgery to local or distant relapse or death. The sample size of the entire trial is 240 eligible patients.

Start Date29 Jun 2023

Sponsor / Collaborator

German Cancer Research Center

NCT05862285 / RecruitingPhase 3

An Open-Label, Multicenter Extension Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Study

The purpose of this extension study is to provide continued treatment with Roche investigational medicinal product (IMP[s]) monotherapy or Roche IMP(s) combined with other agent(s) or comparator agent(s) for eligible participants with cancer who are still on study treatment at the time of roll-over from the parent study and who do not have access to the study treatment locally.

Start Date01 Jun 2023

Sponsor / Collaborator

F. Hoffmann-La Roche Ltd.

100 Clinical Results associated with Ipatasertib Dihydrochloride

100 Translational Medicine associated with Ipatasertib Dihydrochloride

100 Patents (Medical) associated with Ipatasertib Dihydrochloride

118

Literatures (Medical) associated with Ipatasertib Dihydrochloride

01 Nov 2024·Clinical and Translational Medicine

Chaperonin‐containing TCP1 subunit 6A inhibition via TRIM21‐mediated K48‐linked ubiquitination suppresses triple‐negative breast cancer progression through the AKT signalling pathway

Article

Author: Li, Bin ; Tao, Zhonghua ; Wang, Jinyan ; Guo, Duancheng ; Yang, Mengdi ; Hu, Xichun ; Pan, Shuangyue ; Liu, Tiantian ; Cao, Jianing

Abstract:

Background:

Triple‐negative breast cancer (TNBC) is distinguished by a significant likelihood of distant recurrence and an unfavourable prognosis. However, the underlying molecules and mechanisms have not been fully elucidated.

Methods:

We investigated the expression profile and clinical relevance of chaperonin‐containing TCP1 subunit 6A (CCT6A) in TNBC. We performed cell function assays on TNBC cells with CCT6A knockdown or overexpression. To further explore the mechanism of action of CCT6A, RNA sequencing and co‐immunoprecipitation–mass spectrometry analyses were utilized. Rescue and ubiquitination assays evaluated the impact of TRIM21‐mediated CCT6A ubiquitination and degradation on TNBC progression in vitro and in vivo. Finally, we studied the potential of Ipatasertib, a pharmacological AKT inhibitor, and/or anti‐PD1 therapy in inhibiting TNBC progression.

Results:

Elevated CCT6A expression in TNBC patients was associated with an adverse prognosis and lymph node metastasis. Mechanistically, CCT6A facilitated cell migration, invasion, epithelial‐mesenchymal transition and proliferation by activating the phosphatidylinositol 3‐kinase (PI3K)/AKT pathway. The TRIM21 RING domain is an E3 ligase, facilitating the K48‐linked ubiquitination‐mediated degradation of CCT6A, thereby impeding TNBC progression. Moreover, in the tumour tissues of the CCT6A‐overexpressing mice, the quantity of CD8+ T cells and the concentration of secreted interferon‐gamma were decreased, whereas in the group double‐overexpression of CCT6A and TRIM21, they were elevated; the opposite was observed in the knockdown and double‐knockdown groups. Ipatasertib demonstrated enhanced efficacy in inhibiting cell proliferation, invasion and migration in TNBC cells ectopically expressing CCT6A. When Ipatasertib and anti‐PD1 therapies were combined, both the tumour volume and mass exhibited a notable reduction, while the expression of CD45+CD8+ T cells increased, and that of CD45+CD4+CTLA4+ and CD45+CD4+PD1+ T cells decreased.

Conclusions:

Our findings indicate that TRIM21 inhibits TNBC progression by facilitating the K48‐linked ubiquitination‐mediated degradation of CCT6A via the PI3K/AKT signalling pathway. This highlights the potential of Ipatasertib and/or anti‐PD1 as therapeutic strategies, particularly for TNBC patients overexpressing CCT6A.

Key points:

Chaperonin TCP1 subunit 6A (CCT6A) plays an oncogenic role in triple‐negative breast cancer (TNBC) through the AKT signaling pathway.TRIM21 facilitated K48‐linked ubiquitination‐mediated degradation of CCT6A, thereby impeding TNBC progression.Our study collectively underscores the potential of Ipatasertib in conjunction with anti‐PD1 therapy as a promising strategy to counteract CCT6A/AKT hyperactivity‐driven TNBC progression.

01 Nov 2024·EUROPEAN JOURNAL OF PHARMACOLOGY

The efficacy and safety of PI3K and AKT inhibitors for patients with cancer: A systematic review and network meta-analysis

Review

Author: Xun, Fanghua ; Song, Aigang ; Hui, Fuhai ; Wang, Chengkang ; Xu, Ziang ; Ren, Tianshu ; Wang, Shuai ; Xu, Chang ; Hou, Shanbo ; Zhang, Yingshi ; Zhao, Qingchun ; Zheng, Fangyuan ; Xu, Xiangbo ; Geng, Hefeng ; Zhang, Tianqi ; Yang, Kaisi

BACKGROUND:

Inhibiting PI3K/AKT pathway activation may hinder the occurrence and progression of cancer. The aim of this study was to evaluate the efficacy and safety of the PI3K/AKT inhibitors and determine the most appropriate inhibitor for different cancer types.

METHODS:

Electronic databases up to June 2024 were used to examine the efficacy and safety of PI3K inhibitors (alpelisib, copanlisib, duvelisib, and idelalisib) and AKT inhibitors (capivasertib, ipatasertib and MK-2206) for the treatment of cancer. Data was assessed with a random-effect pairwise and network meta-analysis. Randomized controlled trials and retrospective studies were eligible if they compared PI3K or AKT inhibitors with non-PI3K/AKT controls with no restriction.

RESULTS:

The results were based on 34 studies from 34 published articles and 6 online registration trials (6710 patients). According to pairwise meta-analysis, PI3K/AKT inhibitors showed to be highly effective, especially for treating mutant cancers, but had poor safety profiles. According to our network meta-analysis, PI3K/AKT inhibitors, especially the AKT inhibitor capivasertib, are effective for treating solid cancers such as breast cancer (BC). Moreover, PI3K inhibitors, especially idelalisib, were effective for treating hematologic cancers such as chronic lymphocytic leukemia (CLL).

CONCLUSIONS:

The PI3K/AKT inhibitors are effective in patients with genetic mutations. For solid cancers such as BC, capivasertib was efficacy and safety. For hematological cancers represented by CLL, idelalisib was efficacy and safety. The above studies can be used when recommending appropriate targeted therapies for patients with different cancer types.

01 Oct 2024·CLINICAL CANCER RESEARCH

Ipatasertib plus Paclitaxel for Patients with PIK3CA/AKT1/PTEN-Altered Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer in the IPATunity130 Phase III Trial

Article

Author: Kim, Sung-Bae ; O’Shaughnessy, Joyce ; Saji, Shigehira ; Oliveira, Mafalda ; Philco, Manuel ; Bradley, Denise ; Freitas-Junior, Ruffo ; Lian, Qinshu ; Dent, Rebecca A. ; Wongchenko, Matthew J. ; Bondarenko, Igor ; Isakoff, Steven J. ; Reilly, Sarah-Jayne ; Hinton, Heather ; Barrios, Carlos ; Turner, Nicholas

Abstract:

Purpose::

In the randomized phase II LOTUS trial, combining ipatasertib with first-line paclitaxel for triple-negative breast cancer (TNBC) improved progression-free survival (PFS), particularly in patients with PIK3CA/AKT1/PTEN-altered tumors. We aimed to validate these findings in a biomarker-selected TNBC population.

Patients and Methods::

In Cohort A of the randomized double-blind placebo-controlled phase III IPATunity130 trial, taxane-eligible patients with PIK3CA/AKT1/PTEN-altered measurable advanced TNBC and no prior chemotherapy for advanced disease were randomized 2:1 to ipatasertib (400 mg, days 1–21) or placebo, both plus paclitaxel (80 mg/m2, days 1, 8, and 15), every 28 days until disease progression or unacceptable toxicity. The primary endpoint was investigator-assessed PFS.

Results::

Between February 2018 and April 2020, 255 patients were randomized (168 to ipatasertib, 87 to placebo). At the primary analysis, there was no significant difference between treatment arms in PFS [hazard ratio 1.02, 95% confidence interval (CI), 0.71–1.45; median 7.4 months with ipatasertib vs. 6.1 months with placebo]. The final analysis showed no difference in overall survival between treatment arms (hazard ratio 1.08, 95% CI, 0.73–1.58; median 24.4 vs. 24.9 months, respectively). Ipatasertib was associated with more grade ≥3 diarrhea (9% vs. 2%) and adverse events leading to dose reduction (39% vs. 14%) but similar incidences of grade ≥3 adverse events (51% vs. 46%). Exploratory subgroup analyses by PAM50 and Burstein gene expression showed inconsistent results.

Conclusions::

Adding ipatasertib to paclitaxel did not improve efficacy in PIK3CA/AKT1/PTEN-altered advanced TNBC. Biomarkers for benefit from PI3K/AKT pathway inhibition in TNBC remain poorly understood.

News (Medical) associated with Ipatasertib Dihydrochloride

13 Sep 2024

·www.fiercepharma.com

ESMO: AstraZeneca stands by Truqap despite surprise breast cancer flop

The lack of showing for Truqap in gene-altered patients was disappointing as the AstraZeneca AKT inhibitor was expected to work better in this subgroup. As if a limited initial FDA approval was not bad enough, AstraZeneca’s Truqap has recorded a pivotal trial flop that could raise additional doubts around the first-in-class AKT inhibitor. From AZ’s perspective, a company executive argued the failure was probably a one-off.Through and through, the phase 3 CAPItello-290 study was a bust. Truqap, when added to the chemotherapy paclitaxel, failed to extend the lives of patients with newly diagnosed metastatic triple-negative breast cancer or those in a subgroup with alterations in one of the PIK3CA, AK1 and PTEN genes.It was not a close call at all. The death risks between chemo and the Truqap-chemo combo were roughly the same in both analyses, according to data presented at the European Society for Medical Oncology Congress 2024. Patients in the Truqap arm lived a median 17.7 months, versus 18 months for control. In patients with the gene-altered tumors, the median overall survival was the same at 20.4 months between the two arms.While the study was designed to measure the drug’s survival benefits as the primary endpoint, Truqap did show a numerical advantage in reducing the risk of disease progression or death. The AZ drug reduced this risk by 28% compared with paclitaxel in the overall trial population and 30% in the gene-altered subgroup. Apparently, that didn’t translate into any life-extension benefit.The lack of showing in gene-altered patients was particularly disappointing as Truqap was expected to work better in this subgroup. The drug’s initial FDA nod in HR-positive, HER2-negative breast cancer, obtained in November, is limited to gene-altered patients because the FDA saw the most convincing effects there. The addition of Truqap to chemotherapy led to new toxicities in CAPItello-290. Notably, among adverse events that are grade 3 or above, the rates of diarrhea were 12.7% and 0.7% for Truqap and control, respectively. The rate of neutropenia was also slightly higher for AZ's medicine. Adverse events led to an 8.5% rate of treatment discontinuations in the experimental arm, compared with 4.9% in control.Cristian Massacesi, AstraZeneca’s chief medical officer and oncology chief development officer, argued that safety wasn’t the reason behind Truqap’s defeat in TNBC. Instead, he said that the data speak to “the fact that the practice is changing.” Although Massacesi didn’t elaborate, new therapies such as Gilead Sciences’ Trodelvy have emerged as later-line treatments for TNBC since CAPItello-290 commenced in 2019. Strong subsequent therapies may sometimes muddy the effect of a first-line drug, especially around overall survival.The control arm in CAPItello-290 performed markedly better than the control group in the phase 2 PAKT trial, which prompted AZ to move Truqap into phase 3 testing in first-line TNBC. Patients who received chemo alone lived a median 12.6 months in that phase 2 trial but 18 months in the new phase 3 study. In control patients with gene-altered tumors, the median progression-free survival time was 3.7 months in phase 2, versus 5.6 months in phase 3.TNBC was not meant to be Truqap’s core indication, and the CAPItello-290 failure does not affect AZ’s understanding of the drug in other ongoing phase 3 trials, including in HR+/HER2- breast cancer and prostate cancer, Massacesi told Fierce.The CAPItello-292 study was intended to move Truqap one line earlier in the treatment sequence than its existing U.S. indication. Unlike TNBC, the relevance of the PI3K/AKT pathway is very well-established in HR+/HER2- breast cancer, Massacesi noted. There, Novartis’ PI3K inhibitor Piqray has been approved in patients with PIK3CA-mutated tumors.As for prostate cancer, the CAPItello-281 trial, which could read out this year, is only being conducted in metastatic hormone-sensitive prostate cancer that’s PTEN-deficient. In addition, the phase 3 CAPItello-280 trial is testing the addition of Truqap to docetaxel in metastatic castration-resistant prostate cancer (mCRPC). That study was started because AKT activation seems to be a rescue mechanism prostate cancer develops to evade docetaxel, Massacesi explained. The idea is to block that alternative pathway and maximize the effect of docetaxel. Nevertheless, AKT inhibitors’ track record in prostate cancer has not been great. Roche previously dropped development of its AKT inhibitor ipatasertib. The drug showed a tumor progression benefit in a phase 3 trial in mCPRC with PTEN loss but didn’t move the needle on overall survival. Like Truqap, ipatasertib had also failed in TNBC in the IPATunity-170 trial.Truqap might have a different fate; after all, ipatasertib had also missed the mark in HR+/HER2- breast cancer, where Truqap was successful at least in the gene-altered population.Truqap didn’t have the best start when the FDA’s initial approval in HR+/HER2- breast cancer left out patients without mutations along the PI3K/AKT pathway despite a positive phase 3 trial readout in the overall population. AZ is still following the phase 3 CAPItello-290 trial for a longer overall survival analysis, and Massacesi said the company will share more data when the time is right.

Phase 3Clinical ResultDrug ApprovalClinical Trial TerminationGene Therapy

02 Jun 2024

·www.prnewswire.com

MEDSIR's PRIMED Study Shows Promising Results for Preventing Sacituzumab Govitecan related Side Effects in the Treatment of HER2-negative Advanced Breast Cancer

The PRIMED study found a way to reduce treatment-related side effects among participants, decreasing dose reductions, treatment interruptions, and permanent discontinuations. The strategic alliance between MEDSIR and Oncoclínicas has enabled the company to present 13 studies at the 2024 ASCO Annual Meeting. CHICAGO, June 2, 2024 /PRNewswire/ -- Leading international medical research company, MEDSIR, today announced the results of the recent PRIMED clinical trial during the 2024 ASCO Annual Meeting. Carried out under the company's collaborative model, this Investigator-Initiated Trial (IIT) demonstrated the effectiveness of preventative administration of drugs to treat the common side effects of neutropenia and diarrhea that can occur while taking sacituzumab govitecan, an antibody-drug conjugate targeting Trop-2 that has extended overall survival for patients with pretreated triple negative and HR-positive/HER2-negative advanced breast cancer in two previous Phase 3 studies, ASCENT and TROPiCS-02. In the PRIMED study, adding primary prophylactic granulocyte colony-stimulating growth factors (G-CSF) and loperamide during the first two sacituzumab govitecan treatment cycles led to clinically meaningful reductions in neutropenia and diarrhea, lowering the need for dose reductions, treatment interruptions, and permanent discontinuations. Continue Reading Dr. Antonio Llombart-Cussac and Dr. Javier Cortés at ASCO24 Dr. Antonio Llombart-Cussac and Dr. Javier Cortés at ASCO "This is an exciting finding that highlights the high potential of prophylactic strategies that can mitigate side effects to help keep patients on promising treatments, which was made possible by our collaborative research model," shared Dr. Antonio Llombart-Cussac, Senior Scientific Leader of MEDSIR. "By using a partnership model that combines the benefits of company-sponsored research with all the advantages of IITs, we are turning brilliant ideas into full clinical trials that will safely and efficiently advance cancer solutions. It is our hope that, by working together, we will continue to generate new opportunities for patients worldwide." Among PRIMED study participants, the incidence of any grade of neutropenia (in the first two cycles) was 28%, compared to 63% and 70% in ASCENT and TROPiCS-02 (in the full study), respectively. The incidence of any grade diarrhea (in the first two cycles) was 34%, compared to 59% and 57% in ASCENT and TROPiCS-02 (in the full study), respectively. The other side effects PRIMED study participants experienced were consistent to the known safety profile of sacituzumab govitecan, with the exception of constipation, which occurred in 46% of patients during the first two cycles compared to 17% in ASCENT and 19% in TROPiC-02 (in the full study). However, most cases of constipation were mild, and no patients experienced adverse events that led to permanent treatment discontinuation. The study, which is still ongoing to evaluate efficacy and collect longer-term safety data, enrolled 50 patients between February 2023 and September 2023 across 10 sites across Spain, providing them with G-CSF and loperamide during the first two sacituzumab govitecan treatment cycles (physician's decision to continue after two cycles). These two drugs are commonly used to treat neutropenia and diarrhea, respectively, but are usually administered only after these side effects occur. In PRIMED, researchers wanted to test whether early administration of these drugs, before patients experienced any neutropenia or diarrhea, could reduce the incidence of these side effects and determine how this affected the need for dose reductions, treatment interruptions, and permanent discontinuations. Showcasing Numerous Promising Collaborative Trials at ASCO PRIMED was not the only trial MEDSIR presented during the ASCO Annual Meeting. It shared the results of several other recent and ongoing studies as well. Recently published in The Lancet, MEDSIR's PHERGain phase II trial (NCT03161353) demonstrated how a third of patients with HER2-positive early breast cancer could be safely treated without using chemotherapy. At the 2024 ASCO Annual Meeting, MEDSIR presented a subanalysis of this study comparing PET scan and magnetic resonance imaging (MRI) results; both tests that participants undergo to observe the evolution of their cancer. The comparative study shows tumor assessments can be analyzed with both PET scan and MRI. Although PET scan is the recommended imaging technique for early treatment response, this exploratory study suggests that MRI could alternatively guide the treatment when PET scan are not available. MEDSIR's PATHFINDER study evaluated the safety, tolerability, and preliminary efficacy of ipatasertib in combination with non-taxane chemotherapy in patients with advanced triple negative breast cancer who had previously experienced tumor progression after treatment with taxane chemotherapy. Study results revealed that combining ipatasertib with capecitabine and eribulin has an acceptable safety profile in these patients, but that adding ipatasertib alongside carboplatin plus gemcitabine proved to be intolerable. Additionally, the combination of ipatasertib and eribulin demonstrated encouraging efficacy, warranting further investigation. TUXEDO-3, one of MEDSIR's ongoing clinical trials in Austria and Spain, is the first study evaluating the efficacy and safety of patritumab deruxtecan as an anti-cancer therapy for patients with pretreated metastatic breast cancer and advanced non-small cell lung cancer with brain metastases, and metastatic solid tumors with leptomeningeal disease. If positive, this study could streamline the introduction of HER3-DXd as a new treatment for these patients who currently have very limited therapeutic options. ABOUT UMMET CANCER NEEDS Unmet cancer needs refer to gaps in resources, support, and treatment options that exist for cancer patients. Addressing unmet cancer needs is crucial to improving quality of life and outcomes for cancer patients. Through the collaborative work of healthcare providers, policymakers, and patient advocacy groups unmet cancer needs can be identified to help provide patients with comprehensive and quality care. ABOUT MEDSIR Founded in 2012, MEDSIR works closely with its partners to drive innovation in oncology research. Based in Spain and the United States, the company manages all aspects of clinical trials, from study design to publication, utilizing a global network of experts and integrated technology to streamline the process. The company offers proof-of-concept support and a strategic approach that helps research partners experience the best of both worlds from industry-based clinical research and investigator-driven trials. To promote independent cancer research worldwide, MEDSIR has a strategic alliance with Oncoclínicas, the leading oncology group in Brazil with the greatest research potential in South America. Learn how MEDSIR brings ideas to life at . SOURCE MEDSIR

Clinical ResultASCOPhase 2Phase 3

23 May 2024

·www.prnewswire.com

Rutgers Cancer Institute and RWJBarnabas Health Set to Unveil Extensive, New Cancer Research Findings at 2024 ASCO Annual Meeting

49 scheduled presentations will explore several types of cancer, as well as the next frontier of health equity NEW BRUNSWICK, N.J., May 23, 2024 /PRNewswire/ -- Clinicians and scientists from Rutgers Cancer Institute and RWJBarnabas Health will lead sessions and present their latest discoveries from their innovative cancer research program at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held in Chicago (and online) from May 30-June 4. A total of 49 accepted abstracts and presentations will cover cutting-edge topics, including two oral sessions highlighting the National Surgical Quality Improvement Program (NSQIP) audit of enhanced recovery after surgery protocols for radical cystectomy, as well as social vulnerability and clinical trial enrollment's role in the next frontier of health equity. Continue Reading Rutgers Cancer Institute and RWJBarnabas Health "Our world-renowned integrated network of researchers and clinicians at Rutgers Cancer Institute and RWJBarnabas Health continues to innovate and investigate strategies that will achieve the best possible outcomes for our patients. This is reflected in the dynamic lineup of presentations featured at the 2024 ASCO Annual Meeting, underscoring our team's commitment and dedication," said Steven K. Libutti, MD, FACS, Director, Rutgers Cancer Institute and Senior Vice President, Oncology Services, RWJBarnabas Health. "As New Jersey's only National Cancer Institute-designated Comprehensive Cancer Center and the leading cancer program in the state, we are at the forefront of advancing cancer research and care to conquer a disease that impacts so many. We look forward to sharing our array of recent advancements and findings at this year's meeting." The research accepted for presentation at ASCO includes one late-breaking abstract, oral and poster sessions as well as publication-only abstracts highlighting data in numerous types of cancer, including breast, colorectal, lymphoma, and lung. Highlights of the accepted abstracts include the following: Findings from a study that assesses how social vulnerability impacts clinical trial enrollment and explores the interaction between race and social vulnerability among patients with one of the top five cancers - breast, prostate, lung, colorectal and pancreas. Findings confirm that neighborhood social vulnerability is a barrier to trial enrollment, even more so among Black patients. Utilization of enhanced recovery after surgery (ERAS) protocols for radical cystectomy has been associated with improved postoperative recovery and shorter hospital stays. This study was designed to assess the impact of increasing compliance to ERAS components on postoperative outcomes in patients who underwent radical cystectomy. Researchers reviewed 3,708 patients from the National Surgical Quality Improvement Program database who underwent radical cystectomy from 2019 – 2021. Updates from CTEP 10492, a Phase 1/1b study investigating the AKT inhibitor ipatasertib with chemoradiation to treat locally advanced head and neck squamous cell carcinoma (HNSCC). The primary objective of this study is to determine the maximum tolerated dose and recommended Phase 2 dose of ipatasertib in combination with definitive chemoradiation therapy (CRT) in locally advanced HNSCC based on dose-limiting toxicities. This phase 1/1b study will be the first to establish safety and preliminary efficacy of ipatasertib combined with standard of care definitive CRT for HNSCC. Data from a Phase 3 clinical trial evaluates the efficacy and safety of odronextamab plus CHOP vs rituximab plus CHOP in previously untreated diffuse large B-cell lymphoma (DLBCL) patients. OLYMPIA-3 is a Phase 3, randomized, open-label, multicenter study of O-CHOP vs. R-CHOP in patients with previously untreated DLBCL and intermediate- or high-risk features. The primary endpoints of the study are the incidence of dose-limiting toxicities, and incidence and severity of treatment-emergent adverse events as well as progression-free survival by independent central review. CIPHER (NCT05333874), a single institution pilot study, evaluated whether trend of circulating tumor DNA (ctDNA) testing during neoadjuvant therapy (NAT) can serve as an early indicator of treatment response and inform disease management in the adjuvant setting. The study included 35 patients with stage II-III triple negative and HER2+ breast cancer and longitudinal ctDNA testing performed during standard of care NAT. The full list of presentations at this year's 2024 American Society of Clinical Oncology Annual Meeting can be found here. About Rutgers Cancer Institute As New Jersey's only National Cancer Institute-designated Comprehensive Cancer Center, Rutgers Cancer Institute, together with RWJBarnabas Health, offers the most advanced cancer treatment options, including bone marrow transplantation, proton therapy, CAR T-cell therapy and complex surgical procedures. Along with clinical trials and novel therapeutics such as precision medicine and immunotherapy – many of which are not widely available – patients have access to these cutting-edge therapies at Rutgers Cancer Institute in New Brunswick, Rutgers Cancer Institute at University Hospital in Newark, as well as through RWJBarnabas Health facilities. For journalists – contact: Krista Didzbalis Corporate Communications Specialist, Strategic Communications, RWJBarnabas Health 732.507.8307 [email protected] For patient appointments/inquiries – contact: 844-CANCERNJ (844-226-2376) SOURCE Rutgers Cancer Institute and RWJBarnabas Health

Phase 3ASCOImmunotherapyClinical ResultCell Therapy

100 Deals associated with Ipatasertib Dihydrochloride

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-	Ipatasertib Dihydrochloride	-	DB11743

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
ER-positive/HER2-negative Breast Cancer	Phase 3	AU	Hoffmann-La Roche, Inc.	27 Jan 2021
ER-positive/HER2-negative Breast Cancer	Phase 3	CA	Hoffmann-La Roche, Inc.	27 Jan 2021
ER-positive/HER2-negative Breast Cancer	Phase 3	NZ	Hoffmann-La Roche, Inc.	27 Jan 2021
Metastatic Triple-Negative Breast Carcinoma	Phase 3	CN	F. Hoffmann-La Roche Ltd.	17 Sep 2020
Metastatic Triple-Negative Breast Carcinoma	Phase 3	CN	Roche China Holding Ltd.	17 Sep 2020
Hormone receptor positive HER2 negative breast cancer	Phase 3	US	Hoffmann-La Roche, Inc.	06 Jan 2018
Hormone receptor positive HER2 negative breast cancer	Phase 3	JP	Hoffmann-La Roche, Inc.	06 Jan 2018
Hormone receptor positive HER2 negative breast cancer	Phase 3	AR	Hoffmann-La Roche, Inc.	06 Jan 2018
Hormone receptor positive HER2 negative breast cancer	Phase 3	AU	Hoffmann-La Roche, Inc.	06 Jan 2018
Hormone receptor positive HER2 negative breast cancer	Phase 3	AT	Roche China Holding Ltd.	06 Jan 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04464174 (PATHFINDER, ASCO2024)	Phase 2	Advanced Triple-Negative Breast Carcinoma PI3K/AKT/mTOR pathway	54	Ipatasertib (IPA) + Capecitabine (CA)	mbmxtucuqm(ucstsnmbgt) = lxualeykvu eegczjiusv (kkqnqjxjvp ) View more	Positive	24 May 2024
				Ipatasertib (IPA) + Eribulin (E)	mbmxtucuqm(ucstsnmbgt) = dtatdenfrm eegczjiusv (kkqnqjxjvp ) View more
NCT04177108 (IPATunity170, CTgov)	Phase 3	Triple Negative Breast Cancer	242	Paclitaxel+Atezolizumab+Ipatasertib (Cohort 1 Arm A: Ipatasertib + Atezolizumab + Paclitaxel)	ptcdhfuqng(bxndwetjcu) = tuokbbgujx btizxxqzug (zmqxlnnlcn, juqutstirh - tzzroxsqlg) View more	-	27 Mar 2024
				Paclitaxel+Atezolizumab+Ipatasertib (Cohort 2 Arm A: Ipatasertib + Atezolizumab + Paclitaxel)	ptcdhfuqng(bxndwetjcu) = blxozusamg btizxxqzug (zmqxlnnlcn, haboujdsgu - pkqlcecycs) View more
NCT03337724 (IPATunity130, CTgov)	Phase 3	Hormone receptor positive HER2 negative breast cancer	579	Placebo+Paclitaxel (Cohort A: Placebo + Paclitaxel)	tkmakcskui(gxovajnwoy) = fohqtegfoy brvrodlyrj (bfqenjcqcx, rodrkffhgc - xvpedkodsh) View more	-	12 Mar 2024
				Paclitaxel+Ipatasertib (Cohort A: Ipatasertib + Paclitaxel)	tkmakcskui(gxovajnwoy) = akmpgpisss brvrodlyrj (bfqenjcqcx, qhgcosrmxn - iylvoalhym) View more
NCT01485861 (A.MARTIN \| A. MARTIN \| GO27983, CTgov)	Phase 1/2	Castration-Resistant Prostatic Cancer	298	Prednisone+Abiraterone+Prednisolone+Ipatasertib (Phase II: Ipatasertib 400 mg + Abiraterone)	globakhpww(yomvoajvnu) = lasiybihrg fztqothjel (ngblbxtvui, jpjskwlhgk - vqjgmacjtv) View more	-	14 Sep 2023
				Prednisone+Abiraterone+Prednisolone+Ipatasertib (Phase II: Ipatasertib 200 mg + Abiraterone)	globakhpww(yomvoajvnu) = tgaahfmnyn fztqothjel (ngblbxtvui, gyhhtlxycj - gplkeijhmr) View more
NCT03673787 (AACR2023) Manual	Phase 1/2	Glioblastoma Second line PTEN No Expression	19	Ipatasertib+Atezolizumab	zebwiikpbm(pxecpyqvcc) = yyfbpmwysb gyuzagyyce (ribjmoygaw ) View more	Positive	14 Apr 2023
				Ipatasertib+Atezolizumab (pts with PTEN loss)	zebwiikpbm(pxecpyqvcc) = lirgdntysn gyuzagyyce (ribjmoygaw )
NCT04737109 (ADDITION \| BTCRC-GU19-404, ASCO_GU2023) Manual	Phase 1	Castration-Resistant Prostatic Cancer	6	ipatasertib+darolutamide	qchdvxkegp(kglluzwlfs) = fhwdadwvyb ccyycrchdo (uhdtbwqmfq ) View more	Positive	21 Feb 2023
SGO	Not Applicable	Endometrial Carcinoma	-	Ipatasertib	sijjnpnupj(wuchzhxpwx) = nxlymraupe paqgtgthhs (jjyfapdxso )	-	01 Aug 2022
				Carboplatin	sijjnpnupj(wuchzhxpwx) = aghgpznjwq paqgtgthhs (jjyfapdxso )
NCT01896531 (CTgov)	Phase 2	Locally Advanced Gastroesophageal Junction Adenocarcinoma \| Metastatic Gastroesophageal Junction Adenocarcinoma	153	Leucovorin+Ipatasertib+Oxaliplatin+5-fluorouracil (Ipatasertib + mFOLFOX6)	mivestdfcw(dztxfrqcrl) = pwyobogcgg loctobsqqg (rrwlctnubb, tdbvuakmiv - yojlqmauyd) View more	-	17 Feb 2022
				Placebo+Leucovorin+Oxaliplatin+5-fluorouracil (Placebo + mFOLFOX6)	mivestdfcw(dztxfrqcrl) = hjmpamwavn loctobsqqg (rrwlctnubb, fpnpygvxwt - ysvcirolhi) View more
NCT03337724 (IPATunity130, Pubmed \| Breast Cancer Res)	Phase 3	Hormone receptor positive HER2 negative breast cancer	580	Ipatasertib	(xaghglwzgn) = jwnwkcprrw ibuwrpbilb (ncsncrlbig ) View more	Negative	03 Dec 2021
				Placebo	(xaghglwzgn) = bokkyiabvd ibuwrpbilb (ncsncrlbig ) View more
NCT03673787 (Ice-CAP, AACR2021) Manual	Phase 1	Glioblastoma Multiforme PTEN Deletion	10	Ipatasertib+Atezolizumab	qhtmetbeha(hcrdltsakq) = 400mg Ipa OD + 1200mg A Q3W caermlrgfh (wpgdhyxyhi ) View more	Positive	10 Apr 2021

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