Jason Broderick

In patients with metastatic castration-sensitive prostate cancer (mCSPC) treated with apalutamide (Erleada) plus androgen-deprivation therapy (ADT), potential biomarkers of overall survival (OS) outcomes have been identified in an exploratory post-hoc analysis of the phase 3 TITAN trial.

Specifically, “Detection of circulating tumor (ct)DNA or select androgen receptor (AR) and non-AR biomarkers at baseline or end of study treatment (EOST) may be associated with worse survival [with apalutamide/ADT] among patients with mCSPC,” lead study author Neeraj Agarwal, MD, Huntsman Cancer institute, and coauthors wrote in a poster they shared at the 

2022 American Society of Clinical Oncology (ASCO) Annual Meeting

Overall, the TITAN trial (NCT02489318) randomized 1052 patients with mCSPC 1:1 to receive apalutamide plus ADT or placebo plus ADT. Results of the primary and final analyses of the trial showed that adding apalutamide to ADT led to a significant benefit in OS and radiographic progression-free survival versus ADT alone.

For the biomarker analysis, Agarwal et al used next-generation sequencing to analyze ctDNA and genomic aberrations in 17 prostate cancer–related genes at baseline and at EOST. Baseline data were available for 114 patients and EOST data were available for 129 patients. Using statistical modeling, the investigators evaluated associations of ctDNA/aberrations detected at baseline and EOST with OS, as well as associations of ctDNA/aberrations detected at EOST with OS on subsequent therapies.

The investigators reported that the following aberrations occurred in ≥15% of the baseline population across both treatment arms: any genomic 

BRCA1, BRCA2, FANCA, BRIP1, HDAC2, CDK12, ATM, PALB2,

At baseline, 36% (41/114) of patients had detectable ctDNA, of which 27% (11/41) had any genomic 

 gene amplification. In this period from baseline to EOST, there was a significant increase in the presence of these biomarkers. At EOST, 75% (97/129) of patients had detectable ctDNA, of which 67% (65/97) had any genomic 

gene amplification. All of these increases were statistically significant (

There was also an increase in the most prevalent non-

aberrations at BL, however none of these increases was statistically significant:

The investigators also reported that multivariate analyses from both treatment groups showed that the baseline biomarkers of ctDNA (HR, 1.92; 95% CI, 1.11-3.31; 

 genomic aberrations (HR, 6.68; 95% CI, 1.68-26.49; 

 = .0069) were significantly associated with poor OS.

Similarly, multivariate analyses from both treatment groups also showed that the EOST biomarkers of any 

genomic aberration (HR, 1.65; 95% CI, 1.02-2.69; 

pathway aberrations (HR, 2.23; 95% CI, 1.39-3.59; 

The researchers also conducted univariate analyses of the population of patients who were treated with subsequent therapy, comprised of 106 patients who received chemotherapy and 161 patients who received hormonal therapy. The only notable findings with this assessment was that, among patients receiving chemotherapy, OS was worse among patients with 

In their poster summary, Agarwal et al noted, “The predictive value of these biomarkers for survival in mCSPC needs further confirmation.”

Agarwal N, Lucas J, Aguilar-Bonavides C, et al. Genomic aberrations associated with overall survival (OS) in metastatic castration-sensitive prostate cancer (mCSPC) treated with apalutamide (APA) or placebo (PBO) plus androgen deprivation therapy (ADT) in TITAN. J Clin Oncol 40, 2022 (suppl 16; abstr 5066). doi: 10.1200/JCO.2022.40.16_suppl.5066

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Potential biomarkers of overall survival outcomes have been identified in an exploratory post-hoc analysis of the phase 3 TITAN trial.

Survival Biomarkers Emerge for mCSPC in Phase 3 TITAN Study

Partial nephrectomy and complex masses with an imperative indication for nephron-sparing surgery enabled with the use of neoadjuvant axitinib (Inlyta) in patients with clear cell renal cell carcinoma (RCC) who have complex renal masses, acceptable safety, and functional preservation. However, no viable pathway to receive the procedure, according to interim results from the phase 2 PADRES trial (NCT03438708) presented at the 2022 AUA annual meeting.

Explaining the background of the study, lead author Kevin Hakimi, a medical student at the UC San Diego School of Medicine, said, “Up to 25% of patients presenting with renal masses have renal insufficiency or other imperative indications for nephron-conserving management. Further, although partial nephrectomy is increasingly pursued in patients with large or complex masses, a subgroup of patients with imperative indication may not initially have masses that are amenable for partial nephrectomy.”

Accordingly, Hakimiet al launched the single-arm PADRES trial to determine whether neoadjuvant therapy with the TKI axitinib could cytoreduce renal tumors and enable patients with an imperative indication to receive a partial nephrectomy.

There were 26 patients enrolled in the study, with a median age of 69.5 years. Patients had biopsy-confirmed clear cell RCC strongly indicated for partial nephrectomy with the potential for dialysis dependence if given radical nephrectomy. All patients had complex renal masses, which the study defined as a RENAL Nephrometry score in the high range of 10 to 12 and a tumor stage of cT1b to cT3M0.

There were 14 males and 12 females. The ECOG performance status was 0 for nine patients, 1 for fifteen patients, and 2 for two patients.

Patients received oral axitinib at 5 mg twice daily for 8 weeks prior to nephrectomy. The primary end point of the trial was reduction in longest tumor diameter as determined by imaging criteria. Secondary outcome measures included tumor response per RESIST criteria, feasibility of partial nephrectomy, change in RENAL Nephrometry score, survival outcomes, and post-surgical complications.

At a median follow-up of 12 months, the median reduction in tumor size was 19% (

 <.001), with a median size of 7.7 cm prior to axitinib treatment and 6.3 cm after. Axitinib also led to a significant reduction in median RENAL Nephrometry score from 11 to 10 (

 <.001). There were 9 patients (34.6%) who had a partial response per RECIST criteria and the remaining 17 patients had stable disease.

The specific tumor staging pre- vs post-axitinib was as follows: T1a, 0 vs 5 patients, respectively; T1b, 4 vs 3 patients; T2a, 2 vs 0 patients; T3a, 17 patients each; T3b, 3 vs 1 patient.

“Twenty patients initially presented with T3a/T3b disease and 9 patients were downstaged,” said Hakimi.

Regarding the safety of pre-operative axitinib, Hakimi said that 5 patients experienced grade 3 adverse events related to the treatment, consisting of hypertension (n = 3), fatigue (n = 1), and weigh loss (n = 1).

Surgical outcomes showed that 25 patients were able to complete nephrectomy, comprising 19 partial nephrectomies and 6 radical nephrectomies. Twenty four (92.3%) of the patients had negative margins. There were 6 patients who had grade 3/4 post-operative complications.

Hakimi also noted that, importantly, “Patients who underwent partial nephrectomy had preserved renal function.”

Regarding next steps, he said the PADRES trial “continues to accrue with an end goal of 50 patients.”

1. Hakimi K, Campbell S, Nguyen M, et al. Interim analysis of PADRES (prior axitinib as a determinant of outcome of renal surgery nct03438708) clinical trial. Presented during 2022 AUA Annual Meeting; New Orleans, LA. Abstract LBA01-08.

Neoadjuvant axitnib demonstrated significant reductions in tumor size and complexity, allowing for partial nephrectomy in a subgroup of patients with renal cell carcinoma.

Neoadjuvant Axitinib May Enable Partial Nephrectomy in Subgroup of Patients with RCC

Findings from the NeoAvAx trial demonstrate that the combination of the PD-L1 inhibitor avelumab (Bavencio) and the tyrosine kinase inhibitor (TKI) axitinib (Inlyta) is a promising neoadjuvant therapy for patients with high-risk, non-metastatic clear-cell renal cell carcinoma (RCC), according to findings from the NeoAvAx trial presented during the 2022 ASCO Genitourinary Cancers Symposium.

In the open-label, single-arm phase 2 trial, neoadjuvant avelumab/axitinib induced a partial response in 12 (30%) of 40 patients. Median primary tumor downsizing was 20% (range, +3.8%­ to 43.5%). Among patients with a partial response, 10 of 12 were disease-free at the study data cutoff. At a median follow-up of 23.5 months, the median overall survival (OS) and median disease-free survival (DFS) had not yet been reached. No patients had progression of their primary tumor.

“This is the first neoadjuvant trial reporting results from a combination of an immune checkpoint inhibitor (ICI) and VEGFR-TKI for locally advanced high-risk RCC,” said lead study author Axel Bex, MD, PhD, of the Netherlands Cancer Institute.“The DFS data are encouraging, supporting further evaluation, although currently there are no randomized neoadjuvant versus adjuvant ICI trials or neoadjuvant versus adjuvant ICI/VEGFR-TKI combination [trials in this setting].”

Explaining the background of the NeoAvAx trial, Bex said, “Antibodies targeting PD-1/PD-L1 combined with VEGF inhibitors are a first-line standard of care for metastatic RCC. Neoadjuvant use of these combinations may lead to downstaging and reduce the risk of recurrence.”

Overall, there were 40 patients enrolled in the trial between May 2018 and October 2021.

The median patient age was 63 years (range, 47-74), 30% of patients were female, and 70% of patients were male. The World Health Organization performance status was 0 for 30 patients and 1 for 10 patients.

Baseline cTNMwere as follows: T1b-T2b (n = 4), T3a (n = 24), T3b (n = 4), T4 (n = 8). “Ninety percent of the patients had at least a T3 stage disease and higher,” noted Bex. Biopsy grades were G1-2 (n = 27), G3-4 (n = 11), and Gx (n = 2).

Across the population, 42.5% (n = 17) of patients were clinically node positive. “Baseline lymph node diameter was a mean of 2.6 cm and the mean diameter of the primary tumor was 10.3 cm, so by no means was this a low-risk or intermediate-risk population,” explained Bex.

Study dosing was axitinib at 5 mg twice daily and avelumab at 10mg/kg every 2 weeks. The primary end point was partial response at week 12. Secondary endpoints included DFS, OS, and safety, and biomarker analysis on sequential tissue was an exploratory end point.

Overall, 13 (32.5%) patients had disease recurrence and 3 patients died of disease.

Bex said there were no new safety signals with the neoadjuvant regimen as compared with previously reported safety data for axitinib and avelumab. The majority of adverse events (AEs) were grade 1/2. There were 6 total grade 3 AEs, comprising 1 case each of hypertension, infusion-related reaction, fatigue, nausea, hand-foot syndrome, and elevated liver function tests.

Addressing the safety profile of the subsequent surgery patients received after the neoadjuvant regimen, Bex said, “Surgical adverse events were as expected in this patient population with locally advanced RCC.”

Bex also summarized the investigator findings from the exploratory biomarker analysis: “With regards to biomarkers, patients with recurrence had 

 after treatment compared to patients without recurrence. Spatial transcriptomics of post-treatment primary tumor tissue revealed focal intratumoral differences in immune signatures and we are currently investigating this further to see whether this may be one of the reasons why these patients have recurrence.”

The combination of avelumab and axitinib is currently approved by the FDA for the frontline treatment of patients with advanced RCC. The approval was based on results from the pivotal phase III 

, which showed that the combination was associated with a 31% reduction in the risk of disease progression or death compared with sunitinib (Sutent) in patients with treatment-naïve advanced RCC.

1. Bex A, Abu-Ghanem Y, van Thienen JV, et al. Efficacy, safety, and biomarker analysis of neoadjuvant avelumab/axitinib in patients (pts) with localized renal cell carcinoma (RCC) who are at high risk of relapse after nephrectomy (NeoAvAx). J Clin Oncol 40, 2022 (suppl 6; abstr 289). 10.1200/JCO.2022.40.6_suppl.289

2. FDA Approves Bavencio (Avelumab) Plus Inlyta (Axitinib) Combination for Patients With Advanced Renal Cell Carcinoma. Pfizer Oncology. Published May 14, 2019. Accessed February 20, 2022. https://on.pfizer.com/2HtdCzF

NeoAvAx trial results show that neoadjuvant avelumab/axitinib may be beneficial to patients with renal cell carcinoma. 

Neoadjuvant Avelumab/Axitinib Shows Encouraging Efficacy in Renal Cell Carcinoma

Long-term safety data pooled from 3 studies shows that darolutamide (Nubeqa) was well tolerated overall and had comparable safety and tolerability to previously reported data for the androgen receptor inhibitor in patients with metastatic castration-resistant prostate cancer (mCRPC).

The analysis from first author Egils Vjaters, MD, Pauls Stradiņš Clinical University Hospital, and coauthors was presented in a poster at the 

2022 ASCO Genitourinary Cancers Symposium

. Overall, the small study included 13 patients with mCRPC enrolled across the phase 1/2 ARADES (NCT01317641/NCT01429064), phase 1 ARAFOR (NCT01784757), and Japanese Phase 1 (NCT02363855) trials. All 13 patients had received darolutamide for more than 2 years, with a median treatment time of 38 months (range, 24-90).

The median patient age was 68 years (range, 55-81), 12 patients were White, and 1 patient was Asian. The patients were from France (n = 4), the United Kingdom (n = 3), Latvia (n = 3), Finland (n = 2), and Japan (n = 1). The median time since initial diagnosis was 32.4 months (range, 9.7-191.0).

Ten patients had normal renal function (eGFR ≥ 90 mL/min) at baseline and 3 patients had mild renal impairment (eGFR ≥ 60 to < 90 mL/min). Similarly, 10 patients had normal hepatic function at baseline and 3 had mild hepatic impairment. There were 12 patients with a baseline ECOG performance status (PS) of 0, and 1 patient with a baseline PS of 1. Nine patients had a Gleason score ≥ 7 and the remaining 3 patients had a Gleason score of < 7. The median baseline PSA was 18.1 µg/L (range, 4.6-53.6).

Initial treatment patients received for their primary tumor included chemical castration (n = 7), radiotherapy (n = 4), hormonal therapy (n = 1), and prostatectomy (n = 1). Prior and concomitant anticancer therapy patients received before the start of the study treatment included androgen-deprivation therapy (n = 13), bicalutamide (n = 10), triptorelin acetate (n = 6), goserelin acetate (n = 4), leuprorelin acetate (n= 3), cyproterone acetate (n = 3), degarelix acetate (n = 2), and abiraterone acetate (n = 1). There were no patients who had received sipuleucel-T (Provenge), docetaxel, radium-223 (Xofigo), cabazitaxel (Jevtana), or mitoxantrone.

Regarding dosing, the 8 patients from the ARAFOR study and the 1 patient from the Japanese Phase 1 trial received darolutamide at 600 mg twice daily. Among the ARADES patients, 2 were dosed at 700 mg twice daily, and 1 each received 200 mg and 300 mg twice daily, respectively.

All 13 patients experienced treatment-emergent adverse events (TEAEs). Across all reported TEAEs, regardless of whether they were categorized as drug-related, the worst severity was grade 1 or 2 for 7 patients and grade 3 for 6 patients. Six of these all-cause AEs were serious AEs and 1 led to discontinuation of darolutamide. According to the study authors, the discontinuation stemmed from a new locally advanced rectal adenocarcinoma that was not related darolutamide.

Across all of the TEAEs, there were 7 that occurred in more than 2 patients: diarrhea (n = 5), abdominal pain (n = 4), nausea (n = 4), arthralgia (n = 3), fatigue (n = 3), hematuria (n = 3), and influenza (n = 3). All of these cases were grade 1/2 except for 1 case of grade 3 nausea and 1 case of grade 3 hematuria.

There were 5 patients who experienced TEAEs considered to be drug-related. All of these drug-related AEs were grade 1, and none were serious or led to discontinuing darolutamide.

Darolutamide was approved by the FDA in 2019 for the treatment of patients with non-metastatic CRPC. According to the study authors, long-term follow-up for darolutamide in this nonmetastatic setting has consistently shown similar rates of AE-related discontinuation between darolutamide and placebo. With their study, Vjaters et al aimed to show that this positive safety/tolerability profile for darolutamide also extended to the metastatic setting.

1. Vjaters E, Fizazi K, James ND, et al. Long-term safety of darolutamide in patients with metastatic castration-resistant prostate cancer. J Clin Oncol 40, 2022 (suppl 6; abstr 90) doi: 10.1200/JCO.2022.40.6_suppl.090

Based on pooled long-term data, the safety of darolutamide is solidified in patients with metastatic castration resistant prostate cancer.

Darolutamide Sustains Safety in Metastatic Castration Resistant Prostate Cancer

Patients with metastatic castration-resistant prostate cancer (mCRPC) and a high body mass index (BMI) have improved overall survival (OS) vs patients with lower BMI, according to retrospective findings presented during the 2021 European Association of Urology (EAU) Congress.

This phenomenon, a so-called “obesity paradox,” has been reported in other genitourinary malignancies as well.

In an analysis of nearly 1600 patients enrolled across 3 phase 3 trials, the OS rate at 36 months was approximately 30% in patients with obesity (BMI > 30 kg/m

) compared with 20% for patients who were overweight (BMI > 25 to < 30 kg/m

) and normal weight (BMI > 20 to < 25 kg/m

). Statistical modeling showed that the overall risk of death was 4% lower (HR, 0.96; 

 = .015) in patients with obesity when evaluating BMI as a continuous variable and 29% lower (HR, 0.71; 

 = .027) with BMI as a categorical variable.

The investigators also determined that the OS benefit was not caused by the higher chemotherapy dose received by patients with a higher BMI. They found no interaction between BMI subgroups and the dose of docetaxel chemotherapy (

“Looking at patients with metastasis of prostate cancer, we found that [patients with obesity] are living longer. This means that BMI could be used to predict survival in these patients,” study investigator Nicola Fossati, MD, of the Division of Oncology/Unit of Urology at Vita-Salute San Raffaele University in Milan, Italy, stated in a news release.

“This obesity paradox has been seen in some other cancers, possibly due to the relationship between tissue fat and cancer genomes, and more research is needed in this area. It’s also possible that improved survival may be due to the interaction of chemotherapy with other drugs. [Patients with obesity] in this older age group tend to be taking medication for other conditions, and we do not fully understand how these medicines interconnect,” Fossati noted. “Nevertheless, we would not recommend weight gain to anyone with this or another disease. Obesity is a risk factor for many cancers and other diseases, and patients should always aim for a healthy BMI of 18 to 24.”

The study examined 1577 patients with mCRPC enrolled across 3 phase 3 randomized, controlled trials: ASCENT-2 (NCT00273338), MAINSAIL (NCT00988208), and VENICE (NCT00519285). The median patient age was 69 years (interquartile range [IQR], 63-74), and the median BMI was 28 kg/m2 (IQR, 25-31). The median follow-up for survivors was 12 months.

observed with cancer-specific survival. Statistical modeling showed that the risk of cancer-related death was 6% (HR, 0.94; 

 = .002) lower in patients with obesity when evaluating BMI as a continuous variable and 35% lower (HR, 0.65; 

 = .018) with BMI as a categorical variable.

“There are many possible explanations for the association of body weight with positive outcome in metastatic cancers,” Peter Albers, MD, professor and chairman of the Department of Urology at Heinrich-Heine University Düsseldorf in Germany and chair of the EAU Scientific Congress Office, stated in the release.

 “It might be that patients with higher BMI are able to tolerate the toxicity of the treatments and their [adverse] effects better; in prostate cancer, it might be due to the protective impact of hormones found in tissue fat. And it is known that healthy men with slightly higher BMI have a higher overall life expectancy compared to very slim [men].

“However, at the moment, these are just hypotheses. Further research is needed to identify the biological mechanism behind these different outcomes. Until that mechanism is proven, we can’t recommend any change to treatment for patients with advanced prostate cancer.”

1. Cirulli GO, Martini A, Sfakianos JP, et al. The obesity paradox in metastatic castration resistant prostate cancer. Poster presented at: 36th Annual European Association of Urology Congress; July 8-12, 2021; virtual. Accessed August 23, 2021. https://resource-centre. uroweb.org/resource-centre/EAU21/221553/Presentation/

2. Obesity increases survival in advanced prostate cancer. News release. European Association of Urology. July 10, 2021. Accessed July 11, 2021. https://bit.ly/3kbHO7h

A phenomenon known as the “obesity paradox,” has been reported in prostate cancer as well as other genitourinary malignancies.






'Obesity Paradox’ Is Shown in Prostate Cancer

According to updated data from the phase 1b COSMIC-021 trial, treatment with cabozantinib (Cabometyx) and atezolizumab (Tecentriq) continued to demonstrate clinically meaningful activity in previously treated patients with locally advanced or metastatic castration-resistant prostate cancer (mCRPC), including those with high-risk clinical features.

The data presented during the ESMO Congress 2021 included 132 patients, all of whom had prior enzalutamide (Xtandi) and/or abiraterone acetate (Zytiga), and 101 (77%) of whom had high-risk disease. At the data cutoff of February 19, 2021, the investigator-assessed objective response rate (ORR) among all patients was 23%, including 3 complete responses (CRs); the ORR was 15% (all partial responses [PRs]) per independent review.

The investigator-assessed ORR in high-risk patients was 27%, comprising a 2% complete CR rate and a 25% PR rate. Per independent review, the ORR was 18%, comprising all PRs.

At a median follow-up of 15.2 months (range, 5.7-33.9), the median PFS per independent review was 6.8 months in high-risk patients and 5.7 months in the overall population. The median overall survival (OS) was 18.4 months in both the overall and high-risk populations. Based on available data from 75 patients, initial results did not indicate a link between tumor PD-L1 status and clinical activity.

“These detailed results confirm previous findings3 from cohort 6 of COSMIC-021, further suggesting the promise cabozantinib in combination with atezolizumab may hold for patients with high-risk metastatic castration-resistant prostate cancer whose disease progressed following treatment with novel hormone therapy,” Neeraj Agarwal, MD, professor of Medicine, Huntsman Cancer Institute, University of Utah and a trial investigator, stated in a news release.

“A significant number of these patients are looking for treatment options beyond chemotherapy, so these clinically meaningful response rates and progression-free survival results of cabozantinib in combination with atezolizumab are encouraging for this patient community and their physicians,” added Agarwal.

The multicenter, open-label, phase 1b COSMIC-021 trial is evaluating the combination of the PD-L1 inhibitor atezolizumab and the multikinase inhibitor cabozantinib in patients with locally advanced or metastatic solid tumors. The mCRPC cohort is cohort 6 of the trial. Patients in this cohort were allowed to have received prior docetaxel for hormone-sensitive disease. The study design defined high-risk disease as measurable visceral and/or extra-pelvic lymph node metastases. Cabozantinib was administered orally at 40 mg once daily and intravenous atezolizumab was given at 1200 mg every 3 weeks. The primary end point was ORR.

The median patient age was 70 years and 52% (n = 68) had an ECOG performance score of 0. Overall, 42 (32%) patients had visceral metastases and 79 (60%) patients had extra-pelvic lymph node metastases. Regarding prior treatment, 25% of patients had received docetaxel and almost half (45%) of patients had received 2 or more novel hormonal therapies.

The median follow-up time in the high-risk subgroup was 15.8 months. In these patients, the disease control rate was 88% per investigator assessment and 84% per the assessment of the BIRC.

There were no new safety signals that emerged in this updated, expanded cohort analysis as compared with the initial interim analysis. The most common treatment-related adverse events (TRAEs) were diarrhea (55%), nausea (42%), fatigue (43%), and decreased appetite (34%). Over half (55%) of patients experienced grade 3/4 TRAEs. There was 1 reported death related to a TRAE (dehydration in a 90-year-old patient).

Exelixis, the developer of cabozantinib, reported in a news release that based on discussions with the FDA, they will not be filing for regulatory approval of the combination based on the cohort 6 data from COSMIC-021. Instead, the company has launched the phase 3 CONTACT-02 trial (NCT04446117). This ongoing randomized, open-label, study is exploring cabozantinib plus atezolizumab versus second novel hormone therapy (abiraterone, enzalutamide, etc) in patients with mCRPC who previously received 1 NHT to treat metastatic castration-sensitive prostate cancer, non-metastatic CRPC, or mCRPC.

Primary outcomes measures for the trial are OS and PFS, with ORR as a secondary outcome measure. The target enrollment is 580 patients, and there are 62 study locations for the trial in the United States and worldwide. Exelixis noted in their news release that results of this study may support regulatory submissions for the cabozantinib/atezolizumab regimen.

1. Agarwal N, McGregor BA, Maughan BL, et al. Cabozantinib (C) in combination with atezolizumab (A) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): Results of expanded cohort 6 of the COSMIC-021 study. Presented at: 2021 European Society for Medical Oncology Congress. September 16-21, 2021. Abstract LBA24.

2. Exelixis Announces Detailed Phase 1b Results from Cohort 6 of COSMIC-021 Trial in Patients with Metastatic Castration-Resistant Prostate Cancer Presented at ESMO 2021. Published online September 18, 2021. Accessed September 18, 2021. https://yhoo.it/3CvZG2N.

3. Agarwal N, Loriot Y, McGregor BA, et al. Cabozantinib in combination with atezolizumab in patients with metastatic castration-resistant prostate cancer: Results of cohort 6 of the COSMIC-021 study. 

 38: 2020 (suppl; abstr 5564). doi: 10.1200/JCO.2020.38.15_suppl.5564.

According to updated data from the phase 1b COSMIC-021 trial, treatment with cabozantinib and atezolizumab continued to demonstrate clinically meaningful activity in previously treated patients with locally advanced or metastatic castration-resistant prostate cancer, including those with high-risk clinical features.