Jonah Feldman

The FDA has approved elacestrant (Orserdu), an oral selective estrogen receptor degrader (SERD), for use in patients with estrogen receptor (ER)-positive/HER2-negative advanced or metastatic breast cancer.

Elacestrant is the first oral SERD that has shown improved efficacy over standard of care (SOC) treatments in patients with advanced breast cancer.

 The approval was based on data from the phase 3 EMERALD trial (NCT03778931), which randomly assigned patients to receive elacestrant or investigator’s choice of SOC following 1 or 2 prior lines of endocrine therapy including CDK4/6 therapy.

In the EMERALD trial, elacestrant met its co-primary end points of progression-free survival (PFS) in all patients. At 15.5 months median follow-up, elacestrant reduced the risk of progression or death by 30% (HR, 0.70; 95% CI, 0.55-0.88; 

 = .0018) in all patients, with a median PFS of 2.8 months for elacestrant vs 1.9 months with SOC.2 In patients with a confirmed 

 mutation (47.8%), elacestrant reduced the risk of progression by 45% (HR, 0.55; 95% CI, 0.39-0.77; 

The trial population consisted of 477 patients who were randomly assigned 1:1 to receive elacestrant or SOC. They were well-balanced based on baseline characteristics, and were stratified by 

 status, visceral metastases, and previous treatment with fulvestrant (Faslodex). Patients in the experimental arm received 400 mg of elacestrant orally once daily. SOC treatment was investigator’s choice of fulvestrant, anastrozole (Arimidex), letrozole (Femara), or exemestane (Aromasin) monotherapy, according to label and prescribed based on which prior treatments had been used.

Landmark analyses of PFS were conducted at 6 months and 12 months. The 6-month PFS rate was 34.3% (95% CI, 27.2%-41.5%) for elacestrant vs 20.4% (95% CI, 14.1%-26.7%) for SOC, whereas the 12-month PFS rate was 22.3% (95% CI, 15.2%-29.4%) vs 9.4% (95% CI, 4.0%-14.8%), respectively.

In a prespecified interim overall survival (OS) analysis, there were 149 OS events, with a hazard ratio of 0.75 favoring elacestrant (95% CI, 0.54-1.04; 

In terms of safety, adverse events (AEs) occurred in 92.0% of patients who received elacestrant vs 86.0% in the SOC arm, but 63.3% and 43.7%, respectively, were deemed treatment-related by investigators. Grade 3 or 4 AEs occurred in 27.0% in the elacestrant arm and 20.5% in the SOC arm, whereas only 7.2% and 3.1% were deemed treatment-related AEs. AEs led to discontinuation in 15 patients (6.3%) in the elacestrant arm and 10 patients (4.4%) in the SOC arm. The most common any-grade AE was nausea in 35.0% of the elacestrant arm and 18.8% of the SOC arm; grade 3 nausea occurred in 2.5% of the elacestrant arm and 0.9% of the SOC arm.

1. FDA approves elacestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer. News Release. FDA. January 27, 2023. Accessed January 27, 2023. https://bit.ly/3WHsEq8

2. Bidard FC, Kaklamani VG, Neven P, et al. Elacestrant (oral selective estrogen receptor degrader) versus standard endocrine therapy for estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: results from the randomized phase III EMERALD trial. 

. 2022;40(28):3246-3256. doi:10.1200/JCO.22.00338

Articles

Elacestrant has recieved FDA approval for the treatment of patients with estrogen receptor-positive/HER2-negative advanced or metastatic breast cancer.

FDA Approves Elacestrant for ER+/HER2- Advanced Breast Cancer

A premarket approval application for a noninvasive diagnostic screening test for colorectal cancer (CRC) and advanced adenomas (AA) was submitted to the FDA by Geneoscopy Inc, according to a press release.

The test’s effectiveness is supported by the results of the CRC-PREVENT trial (NCT04739722), where it showed high specificity for CRC and AA. The test elicited 94% sensitivity for CRC and 45% sensitivity for AA in average-risk individuals, which is the highest reported sensitivity for any prospective study of a noninvasive screening test.

“We are committed to closing this gap for patients who require screening and look forward to working with the FDA to bring a convenient and reliable screening option to patients that may allow for earlier detection and treatment – and potentially save lives,” Erica Barnell, PhD, chief science officer and Geneoscopy’s co-founder, said in a press release.

The screening test, which received the FDA’s breakthrough designation in January 2021, is based on extracting eukaryotic RNA biomarkers from stool samples to be analyzed at Geneoscopy’s St. Louis-based laboratory.

The CRC-PREVENT trial included 8289 individuals across more than 2900 zip codes in the contiguous United States, which enabled the trial to assess the test’s performance in individuals in different demographics and socioeconomic circumstances.

Participants used a collection kit to submit samples by express mail to be analyzed, and underwent an optical colonoscopy examination. Investigators performed a comparative analysis of the findings of the screening test and the colonoscopy for sensitivities and specificities, including CRC, precancerous AA, high-grade dysplasia, other adenomas, and negative findings.

Sensitivity was determined by the percentage of individuals whose diagnosis by colonoscopy was detected as positive by the screening test. Specificity was determined by the percentage who were found to have benign polyps or no findings on colonoscopy who had a negative test.

In addition to its high sensitivity for CRC and AA, the test showed 88% specificity for no findings on a colonoscopy, which is required to reduce the rate of false positivity that could lead to unnecessary colonoscopies.

 In the 45-49 age population, the test showed 100% sensitivity for CRC and 44% sensitivity for AA, at an 89% specificity. This younger age group is now included as a recommended screening population by the United States Preventive Services Task Force and the American Cancer Society.

 This is the first prospective study where a stool-based test was able to detect CRC in individuals 45-49 years of age.

“Over 50 million Americans between the ages of 45 and 85 are eligible to be screened for CRC,” Barnell said in the press release.

 “Unfortunately, despite CRC being the second leading cause of cancer death in the US, millions of eligible Americans do not get screened – many due to a lack of knowledge of the importance of screening, lack of access to screening and concerns about the invasive nature of options like colonoscopy.”

Following the FDA’s review of the premarket approval application, the screening test could be made available commercially for use in the US, allowing a noninvasive option for earlier detection of CRC.

1. Geneoscopy submits premarket approval application to FDA for its noninvasive colorectal cancer RNA biomarker screening test. News release. Geneoscopy. January 24, 2023. Accessed January 26, 2023. https://bit.ly/3R7pqLa

2. Geneoscopy’s noninvasive colorectal cancer screening test demonstrates high sensitivity and specificity in large pivotal clinical trial. News release. Geneoscopy. January 10, 2023. Accessed January 26, 2023. https://bit.ly/3DdBZPx

Results from the CRC-PREVENT trial of a noninvasive diagnostic screening test have led to the submission of a premarket approval application to the FDA for patients with colorectal cancer and advanced adenomas. 

Premarket Approval Submitted for Noninvasive CRC Screening Test

Patients who received tislelizumab as frontline therapy for unresectable hepatocellular carcinoma (HCC) had superior health-related quality of life (QOL) outcomes versus those who received sorafenib (Nexavar), according to results presented at the 2023 Gastrointestinal Cancers Symposium.

In the RATIONALE-301 trial (NCT03412773), tislelizumab demonstrated improved EORLC GHS/QoL (European Organisation for Research and Treatment of Cancer Global Health Score/Quality of Life) scores, physical functioning, fatigue, and HCC symptom index versus sorafenib. However, it did not significantly reduce pain compared with sorafenib. QOL was maintained from cycle 4 to 6 in the tislelizumab arm whereas patients who received sorafenib deteriorated more significantly over the treatment period.

“Liver cancer represents a global health burden and while there have been advances of recent in the management of the disease, still new treatments are required,” Richard S. Finn, MD, a professor at UCLA’s Geffen School of Medicine, stated in his presentation.

The global phase 3 RATIONALE-301 trial randomly assigned 674 patients to receive tislelizumab, an IgG4 anti–PD-1 monoclonal antibody, or sorafenib, a tyrosine kinase inhibitor (TKI). The efficacy results of the study 

 noninferiority of tislelizumab versus sorafenib for overall survival and objective response rate (ORR), as well as showing improvements in tolerability.

The participants in this study had treatment-naive HCC, Child-Pugh class A, ECOG performance status of 0 or 1, and no tumor thrombus involving main the trunk of portal vein, inferior vena cava, or clinical evidence of portal hypertension with bleeding varices at screening.

Health-related QOL was a key secondary end point in the study, and investigators employed 3 patient-reported outcome (PRO) surveys: the EORTC QLQ-C30 questionnaire for physical functioning and fatigue, the HCC-specific QLQ-HCC18 index, fatigue, and pain scores, and the EQ-5D-5L for descriptive purposes. Over 95% completed surveys at baseline, and the adjusted completion rates for both arms at cycle 4 and 6 were greater than 92%.

When looking at the QLQ-C30 survey’s GHS/QoL scores, patients maintained QOL with tislelizumab and QOL declined with sorafenib. The least square mean difference in scores between the arms was 4.3 favoring tislelizumab (95% CI, 1.4 to 7.3; nominal 

 ≤ .01). Tislelizumab’s mean score change from baseline to cycle 4 was -0.7 (95% CI, -3.0 to 1.6) versus -5.1 (95% CI, -7.6 to -2.6; 

= .0037) for sorafenib. At cycle 6, the mean difference increased to 5.0 favoring tislelizumab (95% CI, 1.8 to 8.2; nominal 

 ≤ .01) and the mean score change from baseline to cycle 6 was -0.9 with tislelizumab (95% CI, -3.4 to 1.6) and -5.9 with sorafenib (95% CI, -8.6 to -3.2; 

 = .0022). The hazard ratio (HR) was 0.68 favoring tislelizumab (95% CI, 0.49 to 0.94).

The QLQ-C30 estimated mean physical functioning score showed a difference of 6.4 favoring tislelizumab (95% CI, 4.2 to 8.6; nominal 

 ≤ .01) after 4 cycles of treatment. After 6 cycles, the difference was 6.2 (95% CI, 3.7 to 8.6; nominal 

 ≤ .01) favoring tislelizumab. The HR for reduced physical functioning was 0.46 (95% CI, 0.33-0.64)

When evaluating reported fatigue based on the QLQ-C30 results, the mean difference in reported fatigue score was -7.6 (95% CI, -10.6 to -4.7; nominal 

 ≤ .01) at 4 cycles and -7.6 (95% CI, -10.8 to -4.3;nominal 

 ≤ .01) at 6 cycles. The HR favoring tislelizumab was 0.48 (95% CI, 0.37 to 0.63).

For the EORTC QLQ-HCC18 index score, the HR favoring tislelizumab was 0.53 (95% CI, 0.34 to 0.81; nominal 

 ≤ .01). At cycle 4, the mean difference was -2.3 (95% CI, -3.8 to -0.8; nominal 

 ≤ .01) and at cycle 6 the mean difference was -2.7 (95% CI, -4.7 to -0.7; nominal 

When looking at patient-reported fatigue based on the QLQ-HCC18 questionnaire, the mean treatment difference in fatigue at 4 cycles was -6.2 (95% CI, -9.0 to -3.4; nominal 

 ≤ .01) and at 6 cycles was -6.0 (95% CI, -9.4 to -2.5; nominal 

 ≤ .01), both favoring tislelizumab. The HR for fatigue favoring tislelizumab was 0.60 (95% CI, 0.46 to 0.80).

The QLQ-HCC18 results for patient-reported pain impacting their QOL showed the mean difference in reported pain score was -0.6 (95% CI, -3.3 to 2.1) at 4 cycles and -0.4 (95% CI, -3.6 to 2.9) at 6 cycles. The HR favoring tislelizumab was 0.78 (95% CI, 0.56 to 1.09), not showing a significant difference in reported pain between the 2 study arms.

In the EQ-5D-5L VAS (visual analogue scale) for general health status, patients who received sorafenib appeared to decline further from baseline between cycles 4 and 6. There was a mean change from baseline of -4.3 (standard deviation [SD], 12.92) at cycle 4 and a mean change of -5.4 (SD, 13.09) at cycle 6 with sorafenib, whereas those who received tislelizumab had a mean change of -0.4 (SD, 14.52) at cycle 4 and -0.2 (SD, 17.03) at cycle 6.

These results, along with the improvements in survival, response, and safety shown in the original presentation of the study findings, suggest that overall health-related QOL will be improved with the single-agent immunotherapy versus the TKI.

“In conclusion, RATIONALE-301 met its primary end point of demonstrating noninferiority to sorafenib in the frontline setting. It also met key clinical end points of including increasing ORR, as well as a favorable safety profile consistent with the class of the PD-1 inhibitor,” said Finn. “As we see here in this noninferiority study, QOL readouts favored tislelizumab versus sorafenib. And together these data support the potential of tislelizumab as a frontline option for patients who may not be a candidate for PD-1 doublet therapy.”

1. Finn RS, Qin S, Kudo M, et al. Tislelizumab versus sorafenib in first-line treatment of unresectable hepatocellular carcinoma: Impact on health-related quality of life in RATIONALE-301 population. 

. 2023;41(suppl 4):495. doi:10.1200/JCO.2023.41.3_suppl.495

2. Kudo M, Qin S, Meyer T, et al. Final analysis of RATIONALE-301: Randomized, phase III study of tislelizumab versus sorafenib as first-line treatment for unresectable hepatocellular carcinoma. 

. 2022;33(suppl_7):S808-S869. doi:10.1016/annonc/annonc1089.

Better health-related quality of life outcomes were seen with tislelizumab vs sorafenib in patients with hepatocelluar carcinoma.

Tislelizumab Improves QOL Measures Versus Sorafenib for Frontline HCC

Afamitresgene autoleucel (afami-cel), a T-cell therapy targeting melanoma-associated antigen A4 (MAGE-A4), showed efficacy and an acceptable benefit-risk profile in a phase 1 clinical trial of patients with metastatic solid tumors.

The multicenter phase 1 dose escalation trial (NCT03132922) of 38 patients with 9 different types of pretreated metastatic solid tumors reported an objective response rate (ORR) of 24% (95% CI, 11.4-40.2) for all patients but a 44% ORR (95% CI, 19.8-70.1) among 16 patients with synovial sarcoma.

 However, all patients experienced grade 3 or higher hematologic toxicities.

“These high response rates are significant because patients with synovial sarcoma really have very few options after high-dose chemotherapy with ifosfamide,” David S. Hong, MD, principal investigator and professor of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center, said in a statement.

MAGE-A4 is a cancer/testis antigen expressed in multiple solid cancer types. Afami-cel is an autologous T-cell therapy designed to target a MAGE-A4 peptide on the cell surface.

Investigators in the phase 1 trial screened patients for MAGE-A4 positivity and enrolled 63 eligible patients, but only 60 underwent leukapheresis and 38 received therapy with afami-cel. The disease types included in the trial were synovial sarcoma, myxoid/round cell liposarcoma ovarian cancer, head and neck cancer, urothelial cancer, gastric cancer, esophageal cancer, melanoma, and non–small cell lung cancer. They had received a median of 3 prior lines of therapy (range, 1-8). The majority were under 65 years old (73.7%; n = 28) and were male (57.9%, n = 22).

The primary end points included the number of adverse events (AEs) and serious AEs, dose-limiting toxicities, and persistence of genetically modified T cells. Secondary end points included ORR, duration of response (DOR), and time to progression.

Patients received lymphodepletion therapy with cyclophosphamide and fludarabine prior to dosing of afami-cel. The trial used a 3+3 design for dose escalation of afami-cel across 3 groups and an expansion group. Group 1 received between 0.08 × 10

 cells,and Group 3 received 1.2 × 10

 cells. The expansion group received between 1.2 × 10

 cells. Eligible patients who had a confirmed response could receive a second cell infusion after disease progression.

The disease control rate (DCR) was 74% including 9 partial responses (PR) and 19 patients with stable disease (SD). The DCR for patients with synovial sarcoma was 94% including 7 PRs and 8 with SD. The median DOR was 25.6 weeks (95% CI, 12.286-not reached [NR]) for all patients and 28.1 weeks (95% CI, 12.286-NR) for 16 patients with synovial sarcoma. Three patients with synovial sarcoma were progression-free after 12 months, and 44% were alive at 12 months. Two of these patients received a second infusion after progression but had no response.

In terms of safety, the most common grade 3 or higher treatment-emergent AEs were decreased lymphocyte count in 37 patients (97.4%), decreased white blood cell count in 34 patients (89.5%), and decreased neutrophil count in 33 (86.8%). Non-hematologic AEs were rarely grade 3 or higher.

Twenty-one patients (55.3%) had cytokine release syndrome, 2 of which were grade 3 or 4, and all were resolved. Two patients (5%) had grade 1 or 2 immune effector cell-associated neurotoxicity syndrome/encephalopathy and 6 more had possibly treatment-related neurological AEs. Nine patients reported skin rash potentially related to afami-cel in the expansion cohort, including 3 with grade 3 toxicity.

There were 3 deaths attributed to AEs, 2 of which were potentially related to treatment: a 77-year-old patient with synovial sarcoma died of aplastic anemia following grade 3 cytopenia, and a 71-year-old patient with ovarian cancer died of ischemic cerebrovascular accident following grade 3 neurotoxicity.

The recommended phase 2 dose was determined to be 1.0 × 10

 transduced cells. Based on these results, investigators initiated the phase 2 SPEARHEAD-1 trial (NCT04044768) of afami-cell for patients with synovial sarcoma or myxoid/round cell liposarcoma.

“The overall toxicity from afami-cel was manageable, and we saw evidence of early activity in other cancer types,” said Hong in a statement.

 “These results suggest this is an approach with the potential to work in solid tumors where there are currently no approved cellular therapies.”



1. Novel T cell receptor therapy shows early anti-tumor activity. The University of Texas MD Anderson Cancer Center. January 9, 2023. Accessed January 11, 2023. https://bit.ly/3ityMUT

2. Hong DS, Van Tine BA, Biswas S, et al. Autologous T cell therapy for MAGE-A4+ solid cancers in HLA-A*02+ patients: a phase 1 trial. 

. Published online January 9, 2023. doi:10.1038/s41591-022-02128-z

A phase 1 trial showed efficacy of a novel T-cell therapy targeting MAGE-A4 in solid tumors, particularly synovial sarcoma. 

Afami-cel T-Cell Therapy Shows Early Efficacy in Synovial Sarcoma

Abequolixron (RGX-104) demonstrated early clinical activity when combined with docetaxel in heavily-pretreated patients with non–small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), according to interim study results announced in a press release from Inspirna.

Investigators in a phase 1/2 clinical trial (NCT02922764) reported an overall response rate (ORR) of 38% and a disease control rate (DCR) of 77% in 13 evaluable patients who received abequolixron plus docetaxel for second- or third-line NSCLC or second-line SCLC. The combination was well tolerated.

“The data thus far demonstrate that abequolixron is well tolerated in combination with full-dose docetaxel, while showing encouraging clinical activity suggesting that this drug candidate could be a valuable addition to a current standard-of-care chemotherapy in heavily-pretreated patients with lung cancer,” Hossein Borghaei, DO, MS, chief of the division of thoracic medical oncology at Fox Chase Cancer Center and principal investigator on the study, said in a statement.

Abequolixron is a small molecule liver X receptor agonist that targets apolipoprotein E pathway dysregulation and enhances antitumor immunity by inhibiting tumor angiogenesis, as well as depleting myeloid derived suppressor cells and activating cytotoxic T lymphocytes.

The phase 1/2 trial’s dose escalation portion administered different dose levels and schedules of abequolixron alone or combined with nivolumab (Opdivo), ipilimumab (Yervoy), docetaxel, or pembrolizumab (Keytruda)/carboplatin/pemetrexed (Alimta) in patients with advanced solid tumors and lymphoma.

The recommended phase 2 dose (RP2D) of abequolixron was determined to be 120 mg twice daily, 5 days on and 2 days off. In a phase 2 dose expansion cohort, 17 patients with NSCLC or SCLC were treated with the RP2D plus docetaxel. Thirteen of these patients were evaluable for response per RECIST 1.1 criteria: 5 patients with second- or third-line NSCLC and 8 patients with second-line SCLC. The 38% ORR consisted of 5 partial responses in patients, 4 who had NSCLC and 1 who had SCLC.

Of the 4 patients with NSCLC who responded, 2 had confirmed partial responses and 4 patients were on study treatment for over 19 weeks, including one with ongoing response at 37 weeks. For the 8 patients with SCLC, there were 5 patients who had a best response of stable disease, and 4 remained on therapy for at least 24 weeks without progression. One patient who had a best response of stable disease went on to have central nervous system progression at week 12 but stayed on therapy for 30 weeks without systemic progression.

All 17 patients were evaluated for safety. The most common treatment-related adverse event (AE) reported was fatigue, which occurred in 12 patients. The next most common AEs were diarrhea and nausea which each occurred in 9 patients, then a decrease in appetite in 8 patients, and neutropenia and weight loss each reported in 7 patients. In terms of grade 3 or 4 treatment-emergent AEs, there were 2 incidences of grade 4 neutropenia, 2 incidences of grade 3 fatigue, and 1 incidence each of diarrhea, nausea, and decreased appetite. All other AEs were grade 1 or 2.

The dose expansion cohort of the study is continuing to enroll patients with NSCLC. Another ongoing dose expansion arm of the study is evaluating abequolixron plus ipilimumab as second- or third-line treatment for endometrial cancer.

“These data, while early, clearly show the potential that abequolixron may have in driving deep responses in patients with heavily-pretreated lung cancer,” Masoud Tavazoie, MD, PhD, CEO of Inspirna, said in a statement. “We are excited to begin the new year by announcing these promising data for abequolixron and look forward to sharing more updates as we continue advancing our novel pipeline in difficult-to-treat cancers.”

1. Inspirna announces interim data from phase 1b/2 study of abequolixron (RGX-104) in relapsed or refractory lung cancer. Inspirna. January 5, 2023. Accessed January 6, 2023. https://bit.ly/3GqJNyb

A phase 2 dose expansion cohort which received the investigational agent abequolixron plus docetaxel showed clinical responses in patients with non–small cell lung cancer and small cell lung cancer. 

Abequolixron Plus Docetaxel Shows Promising Efficacy in NSCLC and SCLC

A new formulation of abiraterone acetate called TAVT-45 demonstrated therapeutic equivalence to Zytiga, the currently approved formulation, in patients with metastatic castration-resistant prostate cancer (mCRPC) and metastatic castration-sensitive prostate cancer (mCSPC), according to a press release from Tavanta Therapeutics.

The phase 3 registrational TAVT45C02 trial (NCT04887506) showed equivalent testosterone level at day 9 and 10 and no statistical difference in the decrease of prostate-specific antigen (PSA) levels in patients between TAVT-45, which is formulated as granules for oral suspension, and abiraterone in tablet form.

"The positive results from the TAVT45C02 trial demonstrate that TAVT-45 may provide an easy-to-swallow alternative to Zytiga, benefitting many patients with dysphagia or difficulty swallowing large tablets," Andreas Maetzel, MD, PhD, chief medical officer of Tavanta Therapeutics, said in a statement. "Approximately 20% to 30% of [patients with] cancer, including many patients with prostate cancer, have difficulty swallowing pills and capsules. We believe these patients may benefit from an alternate formulation like TAVT-45 that would allow them to take their much-needed medications in an easier-to-take formulation."

Current formulations of abiraterone acetate given in large tablets are difficult for some patients to swallow and must be taken on an empty stomach. TAVT-45 is a granule formulation of abiraterone acetate that can be reconstituted in water or juice and consumed as an oral suspension. It may also increase the bioavailability of abiraterone and allow a lower dose to be effective.

The global, multicenter open-label phase 3 trial randomly assigned approximately 107 patients with mCRPC or mCSPC to receive either 250 mg of TAVT-45 as a sachet twice daily without respect to food versus 500 mg abiraterone tablets twice daily at least 1 hour before or 2 hours after a meal. Both arms received 5 mg prednisone once or twice daily depending on the disease setting.

The primary end point was blood serum testosterone levels averaged over day 9 and 10 of treatment to determine pharmacodynamics of the 2 formulations. Secondary end points included the percent of patients with a PSA decrease of 50% or greater from baseline over 84 days and additional pharmacokinetics measures.

In addition to meeting the primary end point and the PSA secondary end point, it was reported that the safety profile of TAVT-45 was in line with that of abiraterone in tablet form.

“It is encouraging to see a familiar efficacy and safety profile for TAVT-45, which is consistent with data established for abiraterone acetate as a standard of care in the treatment of metastatic prostate cancer,” Kenneth M. Kernen, MD, a study investigator and partner in the Michigan Institute of Urology, said in a press release. “The positive results from this clinical study further support and validate the use of TAVT-45 as a novel, oral, easy-to-drink formulation of abiraterone acetate. As a physician, this would be a welcome potential treatment alternative that may also help patients adhere to their medication regimens and may ultimately improve clinical outcomes.”

The results of the study will be presented at an upcoming medical meeting and will be submitted for publication.

“Tavanta intends to submit our New Drug Application to the [FDA], while also evaluating strategic options for the commercialization of TAVT-45,” said Lynne Powell, CEO of Tavanta Therapeutics.

1. Tavanta Therapeutics Announces positive top-line results from pivotal phase 3 trial of TAVT-45 for the treatment of metastatic prostate cancer. Tavanta Therapeutics. January 5, 2023. Accessed January 6, 2023. https://bit.ly/3VWn3f4

Positive topline results were announced from a study comparing TAVT-45, a formulation of abiraterone acetate that is easier to swallow, to the current formulation. 