Silas Inman

Alecensa achieved a 98.4% 4-year overall survival rate versus 92.4% with chemotherapy in resected ALK-positive early-stage lung cancer.

Adjuvant treatment with Alecensa (alectinib) elicited a 4-year overall survival (OS) rate of 98.4% for patients with resected ALK-positive early stage non–small cell lung cancer (NSCLC) according to an updated analysis of the phase 3 ALINA study presented at the 

At a median of 48 months of follow-up in the Alecensa arm (130 patients) and 47.4 months in the chemotherapy arm (127 patients), the 4-year OS rate was 92.4% in the comparator chemotherapy group; however, 81.7% of patients in this arm had received a subsequent ALK inhibitor after recurrence, including 58.3% who received Alecensa. The hazard ratio for OS between the two arms was 0.4. The 4-year disease-free survival (DFS) rate was 75.5% with Alecensa compared with 47% with chemotherapy, and the median DFS was not evaluable versus 41.4 months, representing a 65% reduction in the risk of disease recurrence or death.

"This slide may give you impression that you are in the wrong room. No, this is not a breast cancer session," lead investigator Dr. Rafal Dziadziuszko from the Medical University of Gdansk in Poland joked when showing the slide for OS. "This is a lung cancer session which we hoped for so many years. This is due to the activity of Alecensa and also activity of ALK inhibitors in post-chemotherapy setting in those patients who relapsed."

In the ALINA study, patients were randomly assigned one-to-one to receive adjuvant Alecensa or platinum-based chemotherapy following the surgical resection of their ALK-positive NSCLC. Alecensa was administered twice daily at 600 milligrams for two years and chemotherapy was given every three weeks for four cycles.

Adjuvant treatment: therapy given after surgery to lower the risk of the cancer returning.

ALK-positive: describes lung cancer cells with a change in the ALK gene, which drives cancer growth and can be targeted by drugs like Alecensa.

Overall survival (OS): time from treatment start or surgery until death from any cause.

Disease-free survival (DFS): time after treatment during which a patient shows no signs of cancer.

Lobectomy: surgery that removes one section (lobe) of the lung containing the tumor.

ECOG performance status: scale used by doctors to measure how well a patient can perform daily activities.

Investigator-assessed DFS in the intention-to-treat population (comprising patients with stage 1B to 3A disease) as well as the subgroup of patients with stage 2 to 3A disease served as the primary end point. Central nervous system (CNS) DFS and OS were secondary end points.

Baseline patient characteristics were balanced between the arms with patients being slightly younger than in other studies of lung cancer. In the Alecensa group, 79% of patients were below the age of 65 and 65% were never smokers. The ECOG performance status was 0 (55%) and 1 (45%) and the most common stage at diagnosis was 3 (53%). N2 status was seen in nearly half of patients (49%) and most had nonsquamous histology (95%). Lobectomy was the most utilized surgical procedure (97%).

Following recurrence, 24 of 31 patients in the Alecensa arm (77.4%) and 55 of 60 in the chemotherapy arm (91.7%) received a subsequent therapy. For the chemotherapy group, 81.7% of these treatments were ALK inhibitors with 61.3% of patients receiving a subsequent ALK inhibitor in the Alecensa arm. For Alecensa, 29% of patients received subsequent chemotherapy. Radiotherapy was used for 25.8% of those in the Alecensa arm following recurrence and for 16.7% in the chemotherapy arm.

What additional data were reported in the long-term ALINA analysis?

For patients specifically with stage 2 through 3A disease, the DFS rate at 4 years was 74.5% with Alecensa compared with 46.3% with chemotherapy; the median DFS was not evaluable and 41.4 months respectively. DFS favored Alecensa across all subgroups including for stages, nodal status and race, Dziadziuszko noted.

The CNS DFS was also improved with Alecensa in the ITT population with a 63% reduction in the risk of this event occurring with the ALK inhibitor. The 4-year CNS DFS rate was 90.4% with Alecensa compared with 76.1% with chemotherapy.

"This is an important end point since ALK-positive disease has a predominance for brain dissemination," said Dziadziuszko.

Side effects were similar to prior assessments of the study, said Dziadziuszko. In the label, the most common side effects were hepatotoxicity, constipation, myalgia, COVID-19, fatigue, rash and cough.

"Alecensa continues to demonstrate a robust and durable disease-free survival benefit over chemotherapy with a hazard ratio that is consistently below 0.4 and also benefiting the reduction of risk of CNS recurrence," Dr. Marcello Tiseo, Department of Medicine and Surgery at the University of Parma in Italy, said during a discussion of the results. "OS data are still immature but the magnitude and durability of DFS improvement coupled with a well-tolerated safety profile reinforce Alecensa as a standard of care for resected ALK-positive NSCLC."

In reference to the OS data, Tiseo proposed more work should be done to examine the duration of therapy as many of the progression events occurred only after treatment was stopped at two years. "The 4-year OS [rate] of [98.4]% and in particular the trend toward improvement in OS despite [most] patients receiving a TKI at recurrence suggests the possibility of curing these patients," he said.

Based on an earlier assessment of the ALINA trial, the FDA approved adjuvant Alecensa for patients with ALK-positive NSCLC in April 2024. This approval was made under the FDA's Project Orbis initiative, the Real-Time Oncology Review program and Assessment Aid, each designed to help expedite impactful treatments for patients. The approval was granted one month ahead of schedule.

“Updated results from the phase 3 ALINA study of adjuvant Alecensa versus chemotherapy in patients with early-stage ALK-positive non-small cell lung cancer” by Dr. Rafal Dziadziuszko, et al., 

“FDA approves Alecensa as adjuvant treatment for ALK-positive non-small cell lung cancer” by Dr. Rafal Dziadziuszko, et al., 

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Articles

Alecensa (alectinib) demonstrated a 4-year overall survival (OS) rate of 98.4% in patients with resected ALK-positive early-stage non-small cell lung cancer (NSCLC) in the phase 3 ALINA study. Compared to chemotherapy, Alecensa significantly improved disease-free survival (DFS) and reduced the risk of central nervous system (CNS) recurrence. The study highlighted Alecensa's robust efficacy and tolerable safety profile, reinforcing its role as a standard of care. The FDA approved Alecensa for adjuvant treatment in ALK-positive NSCLC under expedited review programs in April 2024.

Alecensa Improves 4-Year Survival in Early ALK-Positive Lung Cancer

Trodelvy reduced risk of disease progression or death versus chemotherapy in patients with previously untreated metastatic triple-negative breast cancer.

Treatment with Trodelvy (Sacituzumab govitecan) reduced the risk for disease progression or death by 38% versus chemotherapy among patients with previously untreated, locally advanced, unresectable, or metastatic triple-negative breast cancer (TNBC) not eligible for PD-1 or PD-L1 inhibitors, according to data from the phase 3 ASCENT-03 trial presented at the 

In addition to improvements in progression-free survival (PFS), Trodelvy achieved a superior duration of response (DOR) with no new safety signals.

“This data may support a potential new standard and a good option for patients with metastatic TNBC who cannot receive immune checkpoint inhibitors,” said Dr. Javier C. Cortés, head of the International Breast Cancer Centre in Barcelona, Spain.

Among patients treated with Trodelvy, median PFS was 9.7 months versus 6.9 months with chemotherapy. PFS rates were higher with Trodelvy compared with chemotherapy at 6 months (65% versus 53%) and 12 months (41% versus 24%). Investigator-assessed PFS was 9.6 months with Trodelvy versus 6.8 months with chemotherapy. Six- and 12-month PFS rates were 65% and 52% with Trodelvy versus 38% and 22% with chemotherapy.

Progression-Free Survival (PFS): The length of time during and after treatment that a patient’s cancer does not get worse.

Objective Response Rate (ORR): The percentage of patients whose cancer shrinks or disappears after treatment.

ECOG Performance Status: A scale from 0 to 5 that doctors use to describe how well a patient can carry out daily activities, with 0 being fully active and higher numbers indicating more limitation.

Overall Survival (OS): The length of time from the start of treatment that patients are still alive.

Duration of Response (DOR): How long a patient’s cancer stays shrunk or disappears after responding to treatment.

Intravenous (IV): A way of giving medicine directly into a vein using a needle or tube.


PFS benefit was observed across all subgroups, including by age, ECOG performance status, geographic region, disease state, PD-L1 status, and prior chemotherapy. Objective response rate (ORR) was 48% with Trodelvy versus 46% with chemotherapy. Complete response occurred in 20 patients (7%) versus 15 patients (5%), partial response in 115 (41%) versus 112 (40%), stable disease in 113 (41%) versus 101 (36%), and progressive disease in 14 (5%) versus 36 (13%).

“Objective response rates were similar; however, duration of response was substantially longer with Trodelvy,” Cortés noted. Median DOR was 12.2 months versus 7.2 months with chemotherapy. Time to response was 1.6 months in both groups.

Overall survival (OS) data were not mature at presentation. Among 179 patients who initiated subsequent treatment after chemotherapy, 147 (82%) received Trodelvy. Median OS was 21.5 months versus 20.2 months. Median PFS2 was 18.2 months versus 14.0 months.

Side Effects of Trodelvy During the ASCENT-03 Trial

Median treatment duration with Trodelvy was 8.3 months. Treatment-emergent side effects occurred in 99% versus 97% of patients, with grade 3 or higher side effects in 66% versus 62% and treatment-related events in 61% versus 53%.

There were 71 serious side effects in the Trodelvy arm, 46 treatment related. Side effects led to treatment discontinuation in 10 patients, dose interruptions in 181, and dose reductions in 101. Seven side effects led to death, mostly infections, including five secondary to neutropenia. None of the five patients at risk for febrile neutropenia received prophylaxis with G-CSF.

Most common grade 3 or higher side effects included neutropenia (43%), diarrhea (9%), and leukopenia (7%). Side effects leading to discontinuation occurred in 4% versus 12%.

“Chemotherapy has been the mainstay for metastatic TNBC, and absolute improvements in median OS have been modest,” said Dr. Ana C. Garrido-Castro, Dana-Farber Cancer Institute and Harvard Medical School.

“Approximately 25% to 30% of patients with metastatic TNBC do not survive 6 months from diagnosis, roughly the median PFS of first-line chemotherapy. A new drug that significantly improves PFS with acceptable toxicity should change the first-line standard of care.”

Most patients with previously untreated metastatic TNBC are not candidates for PD-1 or PD-L1 inhibitors. About half do not receive a second-line therapy. “The majority will experience progressive disease and need subsequent therapies. Improved options in earlier lines are urgently needed,” Cortés added.

Trodelvy is approved for metastatic TNBC in the second line and beyond and for pre-treated HR-positive/HER2-negative metastatic breast cancer globally.

In ASCENT-03, patients with previously untreated, locally advanced, unresectable, or metastatic TNBC not eligible for immune checkpoint therapy were randomized 1:1 to receive intravenous (IV) Trodelvy on days 1 and 8 of 21-day cycles (279 patients) or chemotherapy (279 patients).

Treatment continued until progression or unacceptable toxicity. Eligible patients could cross over to second-line Trodelvy after progression. Patients were eligible if not candidates for PD-1 or PD-L1 inhibitors and were 6 months or less since curative treatment. Previously treated stable central nervous system metastases were allowed. PFS by served as the primary end point. Secondary end points included OS, ORR, DOR, time to response, safety, and quality of life.

Median age was 56 versus 54. Most patients were White (64% each), ECOG 0 (66% vs 67%), PD-L1 negative (99% each), had lung metastases (59% vs 61%), received prior neoadjuvant therapy (66% vs 68%), and 48% had recurrence ≥12 months after curative treatment.

"Primary results from ASCENT-03: A randomized phase III study of sacituzumab govitecan (SG) vs chemotherapy (chemo) in patients (pts) with previously untreated advanced triple-negative breast cancer (TNBC) who are unable to receive PD-(L)1 inhibitors (PD-[L]1i)." by Dr. Javier C. Cortés, et al. Presented at: 2025 ESMO Annual Congress; October 17-21, 2025; Berlin Germany. Abstract LBA20.

"Sacituzumab Govitecan in Untreated, Advanced Triple-Negative Breast Cancer," Dr. Javier C. Cortés. 

Trodelvy in Metastatic Triple-Negative Breast Cancer Supported by Phase 3 Trial

Adding Truqap to Zytiga, prednisone, and ADT extended radiographic progression-free survival by 7.5 months in PTEN-deficient prostate cancer.

The addition of the oral AKT inhibitor Truqap (capivasertib) to Zytiga (abiraterone acetate), prednisone and androgen deprivation therapy (ADT) extended investigator-assessed radiographic progression-free survival (rPFS) by 7.5 months compared with Zytiga, prednisone, ADT, and placebo in patients with PTEN-deficient de novo metastatic hormone-sensitive prostate cancer, according to results presented at

After a median follow-up of 18.4 months, median rPFS with Truqap was 33.2 months compared with 25.7 months for placebo. Median overall survival was not yet reached at the time of analysis for either arm. There had been 267 events at the time of assessment, with 129 in the Truqap arm and 138 in the placebo group.

“The primary end point was met, showing an rPFS benefit with Truqap and Zytiga, with consistent benefits across clinical end points,” said Dr. Karim Fizazi, medical oncologist at Institut Gustave Roussy and Centre Oscar Lambret. “The rPFS in the control arm was only 25.7 months, highlighting the poor prognosis of this PTEN population.”

In the study, 1,012 patients received Zytiga at 1,000 milligrams (mg) with prednisone at 5 mg daily plus ADT. Patients were randomly assigned to Truqap at 400 mg twice daily for four days on and three days off (507 patients) or matched placebo (505 patients). PTEN deficiency was defined as more than 90% of malignant cells showing no cytoplasmic staining by immunohistochemistry. About 25% of screened patients met this criterion.

Baseline characteristics were similar between groups. Median age was 67 years with Truqap and 68 years with placebo. Total Gleason score was 8 or more in 78.5% and 79% of patients, and disease risk was high in 61.3% and 65.9%, respectively. Bone was the primary metastatic site in 91.1% and 92.5% of patients, and nearly two-thirds had an Eastern Cooperative Oncology Group performance score of 0, with the remainder scoring 1. About three-fourths of patients had high-volume disease.

Radiographic Progression-Free Survival (rPFS): the length of time during and after treatment in which a patient’s cancer does not worsen as seen on imaging scans, such as CT, MRI, or bone scans.
Overall Survival (OS): the length of time from the start of treatment that patients are still alive, regardless of disease status.
Symptomatic Skeletal Event-Free Survival: the length of time a patient lives without experiencing serious bone-related complications caused by cancer, such as fractures, spinal cord compression, or needing radiation or surgery to the bone.
Castration Resistance: the point at which prostate cancer continues to grow or spread despite therapies that lower testosterone (such as ADT).

“Consistent with the poor prognosis of this PTEN-deficient prostate cancer population, most patients had high-risk, high-volume, high Gleason score disease,” Fizazi said.

Subgroup analyses showed similar improvements in rPFS with Truqap, although none met statistical significance. Time to next treatment was 37 months with Truqap compared with 28.5 months for placebo. Median symptomatic skeletal event-free survival was 42.5 months versus 37.3 months. Events included pathological fracture, spinal cord compression, radiation use, surgical intervention, and death.

Time to castration resistance was 29.5 months with Truqap compared with 22 months for placebo. Median time to PSA progression was not calculable at analysis, with 60 events in the Truqap arm compared with 82 in placebo. Pain progression was too early to measure.

Analyses by PTEN expression showed consistent rPFS benefit across all levels. With PTEN loss in 100% of cells, median rPFS was 34.1 months with Truqap compared with 22.1 months for placebo. Truqap also showed trends toward improved overall survival and secondary end points in higher PTEN-deficient populations.

Side effects were higher with Truqap. Grade 3 (severe) or higher (life-threatening) side effects occurred in 67% of patients versus 40.4% for placebo. Serious side effects occurred in 42.5% versus 26%. Side effects led to discontinuation in 18.3% versus 4.8%. Dose interruptions were required in 62.8% versus 26.8% and dose reductions in 29% versus 3.6%. Side effects leading to Zytiga discontinuation occurred in 9.5% versus 5.4%.

The most common side effects with Truqap compared with placebo were diarrhea (51.9% versus 8%), hyperglycemia (38% versus 12.9%), rash (35.4% versus 7%), anemia (23.9% versus 12.7%), and hypokalemia (22.1% versus 12.7%). “Side effects typical of Zytiga, such as hypertension, hypokalemia, and elevated liver enzymes, were similar between arms,” Fizazi said.
In early 2025, another study exploring Truqap in combination with docetaxel and ADT was halted after an interim analysis suggested potential lack of efficacy.

Outside prostate cancer, Truqap is FDA-approved with fulvestrant (Faslodex) for patients with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer harboring one or more PIK3CA, AKT1, or PTEN alterations after progression on at least one prior endocrine regimen or recurrence within 12 months of adjuvant therapy.

"A phase III study of capivasertib (capi) + abiraterone (abi) vs placebo (pbo) + abi in patients (pts) with PTEN deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC): CAPItello-281," by Dr. Karim Fizazi, et al. Presented at: 2025 ESMO Congress; October 17-21, 2025; Berlin, Germany. Abstract 2383O.

Update on CAPItello-280 phase III trial of Truqap in metastatic castration-resistant prostate cancer. News release. AstraZeneca. April 29, 2025. Accessed Oct. 19, 2025. https://www.astrazeneca.com/media-centre/press-releases/2025/update-on-capitello-280-phase-iii-trial.html

FDA approves capivasertib with fulvestrant for breast cancer. FDA. November 16, 2023. Accessed May 1, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-capivasertib-fulvestrant-breast-cancer

The addition of the oral AKT inhibitor Truqap (capivasertib) to Zytiga, prednisone, and ADT significantly extended radiographic progression-free survival (rPFS) in patients with PTEN-deficient de novo metastatic hormone-sensitive prostate cancer. The study showed a median rPFS of 33.2 months with Truqap compared to 25.7 months with placebo. Despite the promising rPFS results, Truqap was associated with higher rates of severe side effects, leading to more frequent treatment discontinuations and dose adjustments. Subgroup analyses indicated consistent rPFS benefits across various PTEN expression levels.

Truqap Extends Radiographic Progression-Free Survival in Some With Prostate Cancer

In patients with ER-positive, HER2-negative advanced breast cancer, giredestrant and Afinitor reduced risk of disease progression or death.

Among patients with estrogen receptor (ER)-positive, HER2-negative advanced breast cancer previously treated with a CDK4/6 inhibitor, the combination or oral selective estrogen receptor degrader (SERD) giredestrant and Afinitor (everolimus) was associated with a significant reduction in the risk of disease progression or death when compared with standard of care (SOC) endocrine therapy plus Afinitor, according to primary results from the phase 3 evERA trial presented at the 2025 ESMO Congress.

In the intent-to-treat population, the median progression-free survival (PFS) was 8.77 months with giredestrant plus Afinitor compared with 5.49 months with SOC. In a sub-population defined by the presence of the ESR1 mutation, the giredestrant combination elicited a median PFS of 9.99 months compared with 5.45 months for those treated with SOC.

"The combination of giredestrant and Afinitor —an oral SERD and an oral mTOR inhibitor—may represent a new, effective, all-oral treatment option in the post-CDK 4/6 inhibitor setting for patients with ER-positive, HER2-negative advanced disease," lead investigator Dr. Erica L. Mayer, medical oncologist and clinical investigator in the Breast Oncology Center at the Dana-Farber Cancer Institute in Boston, said during a presentation of the results. "Consistent benefit with this regimen was seen across key subgroups. Overall response and duration of response benefits were observed in all patients. Overall survival is immature yet favorable."

Progression-free survival: The time a patient lives without their disease spreading or worsening.

Overall response rate: Patients who responded partially or completely to treatment.

Duration of response: The time that a patient responds to treatment.

Overall survival: The time a patient lives, regardless of disease status.

Stomatitis: Inflammation and soreness of the mouth and lips

Anemia: low count of healthy red blood cells.

Bradycardia: An abnormally slow heart rate.

Photopsia: The appearance of flashing lights or sparkles in your vision, often caused by changes in the eye or retina.

The evERA study enrolled 373 patients and randomly assigned them to giredestrant plus Afinitor (183 patients) or SOC endocrine therapy plus Afinitor (190 patients). Giredestrant was administered at 30 mg and Afinitor was given at 10 mg in both arms. Patients were stratified based on their ESR1 status, site of disease and prior treatment with Faslodex (fulvestrant). Of note, ESR1 mutations were present in 102 of those in the giredestrant arm and for 105 in the SOC group at baseline. The most common SOC therapy was Aromasin (exemestane) (141 patients) followed by Faslodex (39 patients) and Nolvadex (tamoxifen) (six patients).

Baseline demographics and characteristics were balanced across the groups, Mayer mentioned. In the giredestrant arm, the median age was 62 years. Visceral disease was present for 68.9% of patients, most commonly in the liver (89 patients). Bone-only metastases were present for 13.1% of patients. Most patients (76.5%) had received at least one prior line of therapy for advanced breast cancer, with 21.9% having received two and 1.6% having received none. All patients had received a prior CDK4/6 inhibitor. Nearly half of patients had received prior fulvestrant (47%).

Investigator-assessed PFS in the ESR1 subgroup and in the full intent-to-treat (ITT) population were the co-primary end points of the study. Secondary end points included overall survival (OS), objective response rate (ORR), and duration of response (DOR).

The PFS Kaplan-Meier curves separated early and continued to widen, Mayer noted. In the ESR1 group, at six months, 66.1% of those in the giredestrant group remained progression free compared with 38.1% in the control arm. At month 12, the PFS rates were 40.5% and 15.2%, respectively. In the ITT population, the six-month PFS rate was 57.4% with giredestrant compared with 39.6% for SOC. At 12 months, the PFS rates were 34.1% and 18.1%, respectively.

An exploratory analysis found similar PFS rates regardless of the endocrine therapy used in the SOC arm. In the ESR1 group, the hazard ratios for giredestrant/Afinitor compared with Aromasin/Afinitor and Faslodex/Afinitor were 0.4 and 0.44, respectively. For those in the ITT, the HRs were 0.55 and 0.59), respectively.

"Treatment with giredestrant and [Afinitor] has consistent benefit across all key subgroups," Mayer said. "This includes patients with visceral disease, liver involvement, prior treatment with fulvestrant, and I would add, in the ESR1-mutant and wild-type populations."

Interim findings were presented for OS, which had reached 59% maturity in the ESR1 population and 67% maturity in the ITT group. In the ESR1 group, median OS was not yet reached in the giredestrant group compared with 21.03 months for those treated with SOC. In the ITT population, median OS was not yet reached in the giredestrant arm compared with 26.87 months in the SOC arm.

An exploratory analysis was conducted looking at PFS and OS in patients without ESR1 mutations detected. In this subgroup, the median PFS was 5.72 in the giredestrant group compared with 5.52 in the SOC group. The median OS in this group was not reached in either arm.

In the ESR1-mutant group, the ORR was 26.6% with giredestrant compared with 13.8% with SOC. In the ITT group, the ORR was 23.8% with giredestrant and 11.7% with SOC. In those without the ESR1 mutation, the ORR was 20% with giredestrant and 8.7% with SOC.

The median DOR was longer in the giredestrant arm. In the ESR1-mutant population, the median DOR was 14.88 months compared with 7.33 months for SOC. For the ITT group, the DOR was 12.71 months compared with 7.72 months, for giredestrant and SOC, respectively. For those without an ESR1 mutation detected, the median DOR was 12.68 months with giredestrant compared with 7.72 months with SOC.

"Treatment with giredestrant and [Afinitor] led to a consistent doubling in the response rate, seen in the ESR1 population, the ITT population, as well as those without ESR1 mutation," said Mayer. "These were durable responses, as the duration of response was consistently prolonged in all 3 subgroups. Notably, in the ESR1-mutant population, the duration of response doubled from about seven months with standard of care and [Afinitor] therapy to almost 15 months of disease control with giredestrant."

In the investigational arm, the median treatment duration was 7.11 months with giredestrant and 6.03 months for Afinitor. Side effects led to treatment discontinuation for 17% of those in the giredestrant group compared with 11.8% of those in the SOC arm. The median dose intensity was 95.98% for giredestrant and 84.70% for Afinitor. In the control group, the median treatment duration was 4.62 months for endocrine therapy and 4.14 months for Afinitor. The median dose intensity was 96.65% for the endocrine therapy and 87.86% for Afinitor.

The most common all-grade treatment-emergent side effects in the giredestrant and SOC arms were stomatitis (47.2% versus 48.9%, respectively), diarrhea (26.9% versus 22.6%) and anemia (23.6% versus 21%). Of note, Mayer noted that grade 1 (mild)/2 (moderate) bradycardia occurred in 3.8% of those treated with giredestrant compared with 0.5% of those in the SOC group. There were no cases of photopsia seen in the study.

"Assessment of toxicity is influenced by the longer median treatment duration in the giredestrant arm," said Mayer. "Overall, however, the toxicity experience was fairly balanced between the two arms and reflects the known safety profiles of the individual study agents."

According to Roche, the developer of giredestrant, data from the evERA study would be "shared with health authorities, with the aim of bringing this potential treatment option to people as soon as possible," according to a statement from the company.

“Giredestrant (GIRE), an oral selective oestrogen receptor (ER) antagonist and degrader, + everolimus (E) in patients (pts) with ER-positive, HER2-negative advanced breast cancer (ER+, HER2– aBC) previously treated with a CDK4/6 inhibitor (i): Primary results of the phase III evERA BC trial,” by Dr. Erica L. Mayer, et al, presented at: 2025 ESMO Congress; October 17-21, 2025; Berlin, Germany. Abstract LBA16.

“Roche’s phase III evERA data showed giredestrant significantly improved progression-free survival in people with ER-positive advanced breast cancer,” news release; 

https://www.roche.com/media/releases/med-cor-2025-10-18

The combination of giredestrant, an oral selective estrogen receptor degrader, and Afinitor (everolimus) significantly reduced the risk of disease progression or death in patients with ER-positive, HER2-negative advanced breast cancer previously treated with a CDK4/6 inhibitor. The phase 3 evERA trial demonstrated improved progression-free survival (PFS) and overall response rates compared to standard endocrine therapy plus Afinitor. The treatment showed consistent benefits across key subgroups, including those with ESR1 mutations. The safety profile was balanced, with manageable side effects, and the data will be shared with health authorities for potential approval.

Silas Inman

Alecensa Improves 4-Year Survival in Early ALK-Positive Lung Cancer

Trodelvy in Metastatic Triple-Negative Breast Cancer Supported by Phase 3 Trial

Truqap Extends Radiographic Progression-Free Survival in Some With Prostate Cancer

Giredestrant/Afinitor Reduces Progression in Advanced Breast Cancer

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