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Bladder CancerBiological: PembrolizumablenvatinibPlacebo for lenvatinibActiveNot RecruitingArgentinaAustraliaCanadaChinaDenmarkFranceGermanyHungaryIsraelItalyJapanKorea, Republic ofNetherlandsPolandRussian FederationSpainTaiwanTurkeyUnited KingdomUnited States10NCT03898180Phase 3
Study of First-line Pembrolizumab (MK-3475) With Lenvatinib (MK-7902/E7080) in Urothelial Carcinoma Cisplatin-ineligible Participants Whose Tumors Express Programmed Cell Death-Ligand 1 and in Participants Ineligible for Platinum-containing Chemotherapy (MK-7902-011/E7080-G000-317/ LEAP-011)

Study of First-line Pembrolizumab (MK-3475) With Lenvatinib (MK-7902/E7080) in Urothelial Carcinoma Cisplatin-ineligible Participants Whose Tumors Express Programmed Cell Death-Ligand 1 and in Participants Ineligible for Platinum-containing Chemotherapy (MK-7902-011/E7080-G000-317/ LEAP-011)

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PSA-Independent Radiographic Progression in mHSPC

KEY TAKEAWAYS

  • The ENZAMET phase 3 trial aimed to investigate the impact of enzalutamide, focusing on radiographic progression without PSA in mHSPC.
  • Researchers observed worse overall survival in mHSPC participants with radiographic progression without prior PSA progression.

ENZAMET, a randomized trial comparing enzalutamide (ENZA) to a standard non-steroidal anti-androgen (NSAA) in 1125 metastatic hormone-sensitive prostate cancer (mHSPC) participants, demonstrated superior PFS and OS with ENZA. Radiographic progression without prior/concurrent PSA progression (rProg1st) is an emerging biomarker of poor clinical outcomes. Ian D. Davis and his team aimed to determine its frequency and assess enzalutamide’s impact on disease state transition for the ENZAMET cohort.

Researchers used a multi-state Cox proportional hazards regression model to perform an inclusive analysis on the ENZAMET dataset. This model categorized participants into four states: (1) Evt-Free (event-free), (2) rProg1st (radiologic progression without confirmed PSA progression), (3) OtherProg (All Other types of clinical progression events (PSA and treatment switch, excluding death), (4) Death. 

Radiographic progression was documented in 34% (388/1125) of participants, with 10% (114/1125) experiencing radiographic progression without confirmed prior/concurrent PSA progression according to the protocol. Among them, 48% (55/114) were assigned ENZA and 52% (59/114) NSAA. Baseline characteristics of the 114 participants with rProg1st were comparable to the overall ENZAMET cohort and showed no significant differences between ENZA and NSAA groups. ENZA exhibited a delay in both rProg1st (HR 0.66, 95%CI: 0.46 to 0.96, P=0.03) and OtherProg (HR 0.37, 95%CI: 0.31 to 0.44, p<0.001) compared to NSAA. The 5-year OS rates were 24% (95%CI: 18-34) in the rProg1st group versus 42% (95%CI: 38-47) in the OtherProg group. Among those who had not progressed (495/1125) with a median follow-up of 68 months, 8% died from causes unrelated to prostate cancer. As previously reported, ENZA extended overall survival in the entire trial cohort (N=1125, HR 0.70, 95%CI 0.58 to 0.84, P<0.0001).

The study concluded that participants experiencing radiographic progression without prior/concurrent PSA progression demonstrated worse overall survival, irrespective of NSAA or enzalutamide assignment. Enzalutamide significantly reduced hazards and delayed the onset of both rProg1st and OtherProg. Despite the absence of identifiable baseline characteristics, the study advocates for future molecular biological analyses to facilitate early identification of this unique subgroup.

The Study is sponsored by University of Sydney

Source: https://meetings.asco.org/abstracts-presentations/230122

Clinical Trail: https://clinicaltrials.gov/study/NCT02446405

Davis. I D, Martin A J, Zielinski R R, et.al (2024). “Radiographic progression without PSA progression in metastatic hormone-sensitive prostate cancer (mHSPC): A retrospective analysis from the ENZAMET trial (ANZUP 1304).” Presented at ASCO GU 2024 (Abstract 151). 

 

PSA-Independent Radiographic Progression in mHSPC

KEY TAKEAWAYS

  • The ENZAMET phase 3 trial aimed to investigate the impact of enzalutamide, focusing on radiographic progression without PSA in mHSPC.
  • Researchers observed worse overall survival in mHSPC participants with radiographic progression without prior PSA progression.

ENZAMET, a randomized trial comparing enzalutamide (ENZA) to a standard non-steroidal anti-androgen (NSAA) in 1125 metastatic hormone-sensitive prostate cancer (mHSPC) participants, demonstrated superior PFS and OS with ENZA. Radiographic progression without prior/concurrent PSA progression (rProg1st) is an emerging biomarker of poor clinical outcomes. Ian D. Davis and his team aimed to determine its frequency and assess enzalutamide’s impact on disease state transition for the ENZAMET cohort.

Researchers used a multi-state Cox proportional hazards regression model to perform an inclusive analysis on the ENZAMET dataset. This model categorized participants into four states: (1) Evt-Free (event-free), (2) rProg1st (radiologic progression without confirmed PSA progression), (3) OtherProg (All Other types of clinical progression events (PSA and treatment switch, excluding death), (4) Death. 

Radiographic progression was documented in 34% (388/1125) of participants, with 10% (114/1125) experiencing radiographic progression without confirmed prior/concurrent PSA progression according to the protocol. Among them, 48% (55/114) were assigned ENZA and 52% (59/114) NSAA. Baseline characteristics of the 114 participants with rProg1st were comparable to the overall ENZAMET cohort and showed no significant differences between ENZA and NSAA groups. ENZA exhibited a delay in both rProg1st (HR 0.66, 95%CI: 0.46 to 0.96, P=0.03) and OtherProg (HR 0.37, 95%CI: 0.31 to 0.44, p<0.001) compared to NSAA. The 5-year OS rates were 24% (95%CI: 18-34) in the rProg1st group versus 42% (95%CI: 38-47) in the OtherProg group. Among those who had not progressed (495/1125) with a median follow-up of 68 months, 8% died from causes unrelated to prostate cancer. As previously reported, ENZA extended overall survival in the entire trial cohort (N=1125, HR 0.70, 95%CI 0.58 to 0.84, P<0.0001).

The study concluded that participants experiencing radiographic progression without prior/concurrent PSA progression demonstrated worse overall survival, irrespective of NSAA or enzalutamide assignment. Enzalutamide significantly reduced hazards and delayed the onset of both rProg1st and OtherProg. Despite the absence of identifiable baseline characteristics, the study advocates for future molecular biological analyses to facilitate early identification of this unique subgroup.

The Study is sponsored by University of Sydney

Source: https://meetings.asco.org/abstracts-presentations/230122

Clinical Trail: https://clinicaltrials.gov/study/NCT02446405

Davis. I D, Martin A J, Zielinski R R, et.al (2024). “Radiographic progression without PSA progression in metastatic hormone-sensitive prostate cancer (mHSPC): A retrospective analysis from the ENZAMET trial (ANZUP 1304).” Presented at ASCO GU 2024 (Abstract 151). 

 

Darolutamide + ADT Efficacy and Safety in HRLPC

KEY TAKEAWAYS

  • The phase 2 trial aimed to investigate the impact of neoadjuvant darolutamide combined with ADT in patients with HRLPC/VHRLPC undergoing RP.
  • The primary endpoint was to determine PRR and MRD.
  • Researchers noticed that neoadjuvant darolutamide plus ADT demonstrated improved clinical and pathological responses in men with HRLPC/VHRLPC.

Radical prostatectomy (RP) poses challenges with adverse surgical outcomes and heightened disease progression risks in high-risk/very high-risk localized prostate cancer (HRLPC/VHRLPC) patients. Junlong Zhuang and his team aimed to assess neoadjuvant darolutamide, a next-gen androgen receptor inhibitor, combined with androgen deprivation therapy (ADT) for RP in HRLPC/VHRLPC patients.

Researchers performed an inclusive analysis in a multicenter, single-arm phase II clinical trial involving patients aged 18-75 with HRLPC/VHRLPC, defined as Gleason ≥ 8 and/or cT3-4N0-1 and/or PSA ≥ 20 ng/mL. VHRLPC criteria included cT3b-cT4, primary Gleason pattern 5, 2 or 3 high-risk features, and > 4 cores with Grade Group 4 or 5. Eligible patients underwent a 6-month regimen of neoadjuvant darolutamide plus ADT followed by RP. 

The primary endpoint assessed was the pathological response rate, encompassing patients with pathologic complete response (pCR) or minimal residual disease (MRD). Secondary endpoints included safety, PSA progression-free survival (PFS), positive surgical margins rate, downstaging rate, and PSA response rate.

About 30 patients, all undergoing robotic-assisted RP, were enrolled. Median age was 71.0 years (IQR, 65.2-73.0), baseline PSA level was 37.8 ng/mL (IQR, 21.0-94.7). Predominantly, 93.3% had very high-risk localized prostate cancer (VHRLPC); 6.7% had HRLPC with 26.7% N1 disease, 86.7% cT3-4, 90% Gleason 8-10, and 77% PSA ≥ 20 ng/mL. Median prostate volume pre-RP was 19.4 mL (IQR, 15.6-28.4). Post-RP, 27 patients (90%) had undetectable PSA levels (<0.01 ng/mL). Pathological response rate was 40.0%, with 6.7% pCR and 33.3% MRD rates. Downstaging was achieved in 20 patients (66.7%), and positive surgical margins occurred in only 13.3%. The extracapsular extension was noted in 11 patients (36.6%) of cases. 

The study concluded that preoperative administration of darolutamide plus ADT for 6 months significantly enhanced clinical and pathological responses in men with HRLPC/VHRLPC. Furthermore, the intervention demonstrated a favorable safety profile. 

The study is sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Source: https://meetings.asco.org/abstracts-presentations/230315

Clinical Trial: https://clinicaltrials.gov/study/NCT05249712

Zhuang J, Wang Y, Zhang S, et al. (2024). “Neoadjuvant darolutamide plus androgen deprivation therapy for high-risk/very high-risk localized prostate cancer: A multicenter, open-labeled, single-arm phase II trial.”  Presented at ASCO-GU 2024 (Abstract 321).

Abiraterone Combo In HRRm McRpc Patients: BRCAAway

KEY TAKEAWAYS

  • The Phase 2 trial aimed to investigate the efficacy of AR-inhibitor (i) vs PARPi as 1L treatment in mCRPC pts.
  • The primary endpoint was to determine PFS, clinical assessment, or death.
  • Researchers noticed that in mCRPC pts with BRCA1/2 or ATM alterations, the combination of abiraterone/prednisone + olaparib demonstrated superior tolerability PFS.

Deleterious germline or somatic homologous recombination-repair mutations (HRRm) are observed in approximately 20% of metastatic castration-resistant prostate cancer (mCRPC) patients (pts). Previous preclinical studies have indicated synergistic effects between PARP inhibition and androgen receptor (AR)–targeted therapy. The BRCAAway was designed as a pre-selected biomarker in a multicenter, randomized phase-2 study.

Maha H. A. Hussain and her research team aimed to evaluate the efficacy of AR inhibitor (i) alone, PARP inhibitor (PARPi) alone, or their combination as the first-line treatment for mCRPC pts harboring germline and/or somatic mutations in BRCA1/2 or ATM.

Researchers performed an inclusive analysis to assess eligibility criteria for the BRCAAway trial, focusing on front-line mCRPC pts without prior exposure to poly (ADP-ribose) polymerase inhibitors (PARPi), androgen receptor inhibitors (ARi) or chemotherapy for mCRPC. Additionally, participants underwent a washout period for antiandrogen, radiation, and other investigational agents. Eligible pts underwent tumor next-generation sequencing (NGS) and germline testing, with those exhibiting inactivating BRCA1/2 and/or ATM alterations randomized in a 1:1:1 ratio to receive Arm I (abiraterone 1000 mg qd + prednisone 5mg bid), Arm II (olaparib 300 mg bid), or Arm III (olaparib + abiraterone/prednisone).

The primary endpoint of the study was progression-free survival (PFS), evaluated as per RECIST 1.1, PCWG3 criteria, clinical assessment, or death. Secondary endpoints encompassed measurable disease response rate (RR), prostate-specific antigen response rate (PSA RR), and toxicity assessment. Arm I and II pts could cross over at progression.

About 165 pts were initially registered and underwent NGS and germline testing; subsequently, 61 pts with HRRm were randomized into Arms I-III. The median age of the cohort was 67 years (range 42-85), with 55 individuals identified as White and 6 as Black. Prior treatment history revealed 26% of pts had received Docetaxel for metastatic hormone-sensitive prostate cancer (mHSPC), and 3.3% had received Darolutamide/Enzalutamide for non-metastatic castration-resistant prostate cancer (nmCRPC).

Disease site distribution included bone n=44 pts, viscera n=12, lymph nodes n=31, and n=3 in other locations. The median baseline prostate-specific antigen PSA: 14 ng/ml (range 0.15-4,037 ng/ml). HRRm status distribution comprised BRCA1 n=3, BRCA2 n=46, ATM n=11, multiple n=1 (33 germline, 28 somatic).

The median (range) time from randomization to the last encounter for pts still alive was =56: 16 (0.8-60), 15 (4.1-36), and 23 (2.9-56) months (m) in Arms I, II, and III, respectively. Treatment-related adverse events (AEs) were reported in 51 pts, with the most common Grade 3: fatigue n=3, anemia n=2, and ALT increases n=2.

Overall survival (OS) data were not yet mature, with 3 deaths in Arm I and 2 in Arm II. 8/19 pts in Arm I and 8/21 in Arm II crossed over from abiraterone to olaparib or vice versa at progression. Median (95% CI) PFS from crossover to olaparib 8.3 months (5.5, 15) and to abiraterone was 7.2 months (2.8, NR). Median (95% CI) PFS from randomization: olaparib 16 m (7.8-25) and abiraterone 16 m (11-28). RR to crossover treatment: olaparib 38% and abiraterone 25%. PSA RR to crossover treatment: olaparib 50% and abiraterone 63%.

The study concluded that in mCRPC pts with BRCA1/2 or ATM alterations, the combination of abiraterone/prednisone + olaparib demonstrated favorable tolerability and significantly extended PFS compared to using either agent alone or sequentially.

The study is sponsored by Northwestern University

Source: https://meetings.asco.org/abstracts-presentations/230557

Clinical Trial: https://clinicaltrials.gov/study/NCT03012321

Hussain M H A, Kocherginsky M, Agarwal N, et al. (2024). “BRCAAway: A randomized phase 2 trial of abiraterone, olaparib, or abiraterone + olaparib in patients with metastatic castration-resistant prostate cancer (mCRPC) bearing homologous recombination-repair mutations (HRRm).” Presented at ASCO-GU 2024 (Abstract 19).

NAP as an Effective Systemic Therapy Prior to Radical Cystectomy for Cisplatin-Ineligible MIBC

KEY TAKEAWAYS

  • The PURE-01 phase 2 study compared pathologic response and survival outcomes in cisplatin-ineligible patients receiving NAP vs. IRC.
  • OS was analyzed through the Kaplan-Meier method and Log-Rank functions.
  • The variable contribution to survival was measured using the Cox-proportional hazards model.
  • Cisplatin-ineligible patients receiving NAP for MIBC showed significantly better downstaging and survival over those who underwent IRC.

In this study, patients (pts) ineligible for cisplatin and with cT2-4N0M0 muscle-invasive bladder cancer (MIBC) were identified from the PURE-01 trial and evaluated against cisplatin-ineligible MIBC patients who had received immediate radical cystectomy (IRC). Overall survival (OS) was analyzed through the Kaplan-Meier method and Log-Rank functions. The study utilized the Cox-proportional hazards model to determine the variable contribution to survival. Propensity score matching was also conducted for IRC and neoadjuvant pembrolizumab (NAP) pts based on assessments like pre-cystectomy ECOG status, GFR, age, sex, and clinical T stage. An additional exploratory analysis was done to match pts by pathologic T stage. All statistical analysis was performed using R.

In the PURE-01 study, 39 patients who were not eligible for cisplatin treatment were treated with NAP, and compared to 313 cisplatin-ineligible patients who received IRC. The results indicated that those who received NAP had a significantly longer overall survival (OS), with a median survival of not reached (NR) compared to 19 months in the IRC group. This difference was statistically significant (p<0.01). After conducting a propensity match, 39 patients were identified from the IRC cohort with similar clinicopathologic data. Those who received NAP had a higher complete response rate on final pathology than those who did not (pT0: 33% vs. 13%, p=0.03). Additionally, the NAP group had a longer median overall survival (OS) compared to the IRC group (NR vs. 21.0 mo, p<0.01), with significant differences at 12 mo (89% vs. 57%), 24mo (64% vs. 28%), and 36 mo post-surgery (33% vs. 13% ) (p<0.01). Cox Proportional Hazards Modelling showed that patients who underwent IRC had worse OS with a hazard ratio of 2.0 (95% CI 1.1 – 3.89).

Cisplatin-ineligible pts receiving NAP for MIBC demonstrated a higher rate of downstaging and survival advantage over those who underwent IRC. Ongoing prospective randomized trials are underway to validate these findings and provide therapeutic options to patients who cannot tolerate cisplatin.

Source: https://www.auajournals.org/doi/10.1097/JU.0000000000003309.09

Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT02736266

Rose, Kyle; Bandini, Marco; Huelster, Heather; Basile, Giuseppe; Naidu, Shreyas; Spiess, Philippe; Necchi, Andrea; Li, Roger MP56-09 NEOADJUVANT PEMBROLIZUMAB SHOWS PROMISE AS EFFECTIVE SYSTEMIC THERAPY PRIOR TO RADICAL CYSTECTOMY FOR CISPLATIN-INELIGIBLE MUSCLE INVASIVE BLADDER CANCER, Journal of Urology: April 2023 – Volume 209 – Issue Supplement 4
doi: 10.1097/JU.0000000000003309.09

COMET-2 Trial: Treatment Tolerance With Patient-Reported Outcomes Data and Toxicity Index Evaluated

KEY TAKEAWAYS

  • Longitudinal symptomatic adverse events during clinical trials must be summarized to understand treatment tolerability.
  • The PRO-CTCAE is a valuable tool to assess treatment tolerability in clinical trials.
  • The toxicity index can be used to evaluate the PRO-CTCAE data obtained from the COMET-2 clinical trial in conjunction with the highest attainable score.
  • The toxicity index is a useful approach to stratify patients based on the severity of their symptomatic adverse event load, ranging from minimal to maximal.
  • The toxicity index and severity level proportions exhibited analogous outcomes in inter-group statistical variations.
  • Additional research is required to establish a definitive clinical or patient-oriented explanation of the toxicity index.

Summarizing longitudinal symptomatic adverse events during clinical trials is imperative to comprehend treatment tolerability. Utilizing the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) offers valuable information for assessing treatment tolerability in clinical trials. In medical literature and during patient consultations, it is common to employ tolerability summary measures, such as the maximum score, to convey the possible adverse symptoms. Typically, the ratios of prevalent and acute symptomatic unfavorable occurrences are utilized and disclosed between therapeutic groups across categories of unfavorable occurrences.

The toxicity index is a measure that has been utilized in the past to summarize clinician-reported Common Terminology Criteria for Adverse Events (CTCAE) data. The researchers utilize the toxicity index to evaluate the PRO-CTCAE data obtained from the COMET-2 clinical trial in conjunction with the highest attainable score. Subsequently, they provide an overview and analysis of the factors that must be considered while employing the toxicity index as a comprehensive metric for conveying the degree of tolerability to both patients and healthcare providers. The maximum severity levels of PRO-CTCAE and the median toxicity index were calculated for each arm, considering all trial data and adjusting for baseline symptoms.

The inter-group statistical variations exhibited analogous outcomes, regardless of whether the severity level proportions or the toxicity index were employed. Baseline symptom adjustment’s observed effects were comparable when assessing arms based on severity rates or the toxicity index. The employment of the toxicity index is a valuable approach in the stratification of patients based on the severity of their symptomatic adverse event load, ranging from minimal to maximal. The present investigation has demonstrated the feasibility of utilizing the toxicity index in the context of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events. While the tolerability summary measure is useful, additional research is required to establish a definitive clinical or patient-oriented explanation of the toxicity index.

Source Link: https://pubmed.ncbi.nlm.nih.gov/34371138/

Clinical Link: https://clinicaltrials.gov/ct2/show/NCT01522443

Langlais B, Mazza GL, Thanarajasingam G, Rogak LJ, Ginos B, Heon N, Scher HI, Schwab G, Ganz PA, Basch E, Dueck AC. Evaluating Treatment Tolerability Using the Toxicity Index With Patient-Reported Outcomes Data. J Pain Symptom Manage. 2022 Feb;63(2):311-320. doi: 10.1016/j.jpainsymman.2021.07.031. Epub 2021 Aug 8. PMID: 34371138; PMCID: PMC8816875.

A Phase 2 Study on Oral Docetaxel + Ritonavir for mCRPC

KEY TAKEAWAYS

  • ModraDoc006 is an oral form of docetaxel, co-administered with ritonavir to increase bioavailability, and has shown activity against docetaxel-resistant prostate cancer cells.
  • A randomized phase 2b study compared the efficacy of ModraDoc006/r 20-20 mg with 200-100 mg ritonavir administered bi-daily to IV docetaxel 75 mg/m2 in patients with mCRPC.
  • Sixty-two patients with mCRPC, performance status 0-1, and no prior chemotherapy treatment for mCRPC were included in this study.
  • The main outcome measure was rPFS according to the PCWG-3 criteria.
  • The secondary endpoints included ORR, PSA-PFS, time to skeletal-related events, disease control rate, response duration, and safety evaluations.
  • ModraDoc006/r exhibited a promising safety profile and efficacy comparable to IV docetaxel, with superior tolerance and fewer adverse events.

The administration of docetaxel through the intravenous (IV) route and oral prednisone is a widely accepted and recommended treatment protocol for patients suffering from metastatic castration-resistant prostate cancer (mCRPC). The medication known as ModraDoc006 is an oral form of the chemotherapy drug Docetaxel. The co-administration of ritonavir (/r) is employed to augment the bioavailability of ModraDoc006. The combination of ModraDoc006 and ritonavir has demonstrated activity in various prostate cancer cell lines resistant to docetaxel and cabazitaxel. In a randomized phase 2b study conducted on patients with metastatic castration-resistant prostate cancer (mCRPC), an oral combination of ModraDoc006/r was compared to intravenous Docetaxel. The study evaluated two doses of ModraDoc006/r, namely 30-20/200-100 mg and 20-20/200-100 mg. Information regarding the results of the lower dosage administered to a larger group is being presented. Eligible patients had metastatic castration-resistant prostate cancer (mCRPC), a performance status of 0-1, and no previous chemotherapy treatment for mCRPC. A total of sixty-two patients were included in an open-label, randomized study that compared the efficacy of ModraDoc006/r 20-20 mg in combination with 200-100 mg ritonavir administered on a bi-daily weekly schedule (“20-20/200-100 mg”) to that of IV docetaxel 75 mg/m2 given in 21-day cycles. All patients were administered 5 milligrams of oral prednisone twice daily. The main outcome measure was radiographic progression-free survival (rPFS) according to the PCWG-3 criteria. The secondary endpoints comprised objective response rate (ORR), prostate-specific antigen progression-free survival (PSA-PFS), time to skeletal-related events, disease control rate, response duration, and safety evaluations.

A cohort of 31 patients received intravenous administration of docetaxel at a dosage of 75 mg/m2, while another cohort of 31 received ModraDoc006/r at 20-20/200-100 mg. Fifty-seven cases were considered to analyze relative progression-free survival (rPFS), while the objective response rate (ORR) analysis included 32 patients with detectable diseases. The median prostate-specific antigen (PSA) level observed was 46 ng/ml, ranging from 1 to 1460 ng/ml. Eight patients had received prior therapy with enzalutamide, while ten patients had received prior therapy with abiraterone. The ModraDoc006/r treatment exhibited superior tolerance with no incidence of neutropenia or anemia of any grade, in contrast to IV docetaxel which had a 26% occurrence rate (19% ≥G3) and 16% incidence of neutropenia and anemia, respectively. The incidence of neuropathy was significantly lower at 9.7% in Group 1 patients who received ModraDoc006/r compared to 9.7% in Group 1 and 19.4% in Group 2 patients who received IV docetaxel. Similarly, the incidence of alopecia was lower at 16.1% in Group 1 and 6.5% in Group 2 patients who received ModraDoc006/r compared to 22.6% in Group 1 and 19.4% in Group 2 patients who received IV docetaxel. GI toxicities were broadly comparable with diarrhea 32% (3% ≥G3) vs. 29%, nausea 29% vs. 13%, and stomatitis 3% (G3) vs. 13% (3% ≥G3), respectively. The clinical trial ModraDoc006/r exhibited a promising safety profile and efficacy comparable to intravenous docetaxel in patients with metastatic castration-resistant prostate cancer (mCRPC). This outcome presents a convincing justification for implementing an extended pivotal program. The primary clinical program objective is to evaluate the efficacy of ModraDoc006/r in comparison to the most optimal available therapy for patients with refractory metastatic castration-resistant prostate cancer (mCRPC). Active development of studies on ModraDoc006/r in other malignancies is underway.

Source Link: https://meetings.asco.org/abstracts-presentations/208972

Clinical Link: https://clinicaltrials.gov/ct2/show/NCT04028388

Ulka N. Vaishampayan, Marianne Keessen, Elisabeth I. Heath, Robert Dreicer, Tomas Buchler, Péter Ferenc Árkosy, Tibor Csoszi, Pawel J. Wiechno, Denis Kholtobin, Evgeny Kopyltsov, Neal D. Shore, Aleander Nosov, Sergey Orlov, Alexey Plekhanov, Maria Smagina, Sergey Varlamov, Nicholas J. VogelzangA phase 2 randomized study of oral docetaxel plus ritonavir (ModraDoc006/r) in patients with metastatic castration-resistant prostate cancer (mCRPC)/J Clin Oncol 40, 2022 (suppl 16; abstr 5016)DOI 10.1200/JCO.2022.40.16_suppl.5016

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