Ashling Wahner

The combination of first-line Bavencio and Inlyta was effective and safe in advanced RCC; stock.adobe.com

For patients with advanced renal cell carcinoma (RCC), first-line Bavencio (avelumab) in combination with Inlyta (axitinib) was effective and safe in a real-world population and delivered results consistent with those previously reported in clinical trials, according to findings from the primary analysis of the AVION study, which were presented at the 

At a data cutoff date of July 5, 2024, among patients with advanced RCC in Belgium, Germany, Greece, and Russia enrolled in the trial who received the combination in routine clinical practice (104 patients), the median overall survival (OS) was not reached (NR), the six-month OS rate was 89.1%, and the 12-month OS rate was 82.7%.

“Overall, results from AVION demonstrate the effectiveness, safety, favorable tolerability and stable health-related quality of life [HRQOL] of [Bavencio plus Inlyta] in a heterogeneous real-world population,” lead study author Dr. Axel Stuart Merseburger, and coauthors wrote in a poster of the data.

Palmar-plantar erythrodysesthesia syndrome: a condition with redness and pain on the palms and soles, often from cancer treatment.

Hypertensive crisis: a severe spike in blood pressure, typically over 180/120 mm Hg, risking organ damage.

Complete response (CR): no evidence of cancer after treatment.

Partial response: a significant reduction in tumor size, but not complete elimination.

Stable disease: cancer that hasn't worsened or shrunk significantly.

Progressive disease (PD): cancer that is growing or spreading despite treatment.

Overall survival (OS) rate: the percentage of patients alive after a certain time post-treatment.

Duration of OS: the time from diagnosis/treatment to death or end of study.

Progression-free survival (PFS): the time a patient lives without cancer worsening.

Overall response rate (ORR): the percentage of patients whose cancer shrinks or disappears.

Duration of response (DOR): the time cancer remains controlled after treatment.

Disease control rate (DCR): the percentage of patients with CR, partial response, or stable disease.

Stable health-related quality of life (HRQOL): maintaining a stable quality of life despite disease presence.

Dysphonia: voice changes due to cancer or treatment effects on the vocal cords.

Pruritus: itching, often caused by cancer treatments or malignancy.

ECOG performance status of 0/1 or 2: level of functioning, where 0 indicates no symptoms, 1 means mild symptoms and 2 indicates moderate symptoms limiting some activities.

Merseburger is chairman of the Clinic of Urology at University Hospital Schleswig-Holstein in Lübeck, Germany.

Any-grade side effects (AEs) were observed in 83.7% of patients, and grade 3 (severe) or worse AEs were observed in 34.6% of patients. AEs led to discontinuation of Bavencio or Inlyta in 9.6% and 14.4% of patients, respectively.

Any-grade treatment-related AEs (TRAEs) were reported in 67.3% of patients, and grade 3 or worse TRAEs were reported in 20.2% of patients. TRAEs led to discontinuation of Bavencio or Inlyta in 6.7% and 9.6% of patients, respectively.

The most common TRAEs were diarrhea (any-grade, 26%; grade 3 or worse, 4.8%), fatigue (13.5%; 1.9%), hypertension (10.6%; 1%), hypothyroidism (8.7%; 0%), dysphonia (8.7%; 0%), nausea (7.7%; 0%), palmar-plantar erythrodysesthesia syndrome (7.7%; 0%), pruritus (6.7%; 0%), decreased weight (5.8%; 0%), dyspnea (3.8%; 1.9%) and hypertensive crisis (2.9%; 1.9%).

Serious AEs and serious TRAEs were noted in 36.5% and 14.4% of patients, respectively. A total of 10.6% of patients received corticosteroids, immunosuppressants or hormonal therapy to manage any-grade TRAEs.

AEs led to death in four patients, and TRAEs led to death in one patient.

Previously, the phase 3 JAVELIN Renal 101 trial showed that first-line Bavencio plus Inlyta generated significantly longer progression-free survival (PFS), and higher objective response rates (ORRs) compared with Sutent (sunitinib) and had an acceptable, long-term safety profile in patients with advanced RCC. The final analysis of JAVELIN Renal 101 showed that in the overall population, at a minimum follow-up of 68 months, the median PFS was 13.9 months with the combination versus 8.5 months with Sutent. The ORRs in these respective arms were 59.7% and 32%.

Additionally, outcomes from the final OS analysis in the overall population favored the combination arm, although the OS difference between the two arms was not statistically significant. The median OS was 44.8 months with the combination versus 38.9 months with Sutent.

The findings from JAVELIN Renal 101 supported the 2019 FDA approval of Bavencio plus Inlyta for the first-line treatment of patients with advanced RCC. In 2019, the European Commission also approved the combination for this indication.

Despite these data and approvals, the AVION investigators noted that real-world data with the combination in clinical practice are limited.

The prospective, noninterventional AVION study enrolled patients being treated for locally advanced, recurrent or metastatic RCC in Belgium, Germany, Greece, and Russia who had already received one or two doses of frontline Bavencio plus Inlyta; these patients received further treatment with the combination during AVION. Patients needed to be at least 18 years of age, have histologically confirmed disease with any histological origin, and have an ECOG performance status of 0 to 2.

Patients received Bavencio intravenously at 800 milligrams (mg) every two weeks and Inlyta orally at 5 mg twice daily.

The primary end goal was the OS rate at 12 months from the date of the first treatment received after informed consent. Secondary end points included the 24-month OS rate, duration of OS, PFS, ORR, duration of response (DOR), disease control rate (DCR), safety and HRQOL.

In total, 105 patients were enrolled. One patient did not report Inlyta treatment prior to informed consent and was excluded from the analysis population.

Patients had a median age of 70 years; 34.6%, 40.4% and 25% of patients were younger than 65 years of age, between 65 and 75 years of age and older than 75 years of age, respectively. Most were male (70.2%). Additionally, 89.4%, 3.8% and 6.7% of patients had clear cell, sarcomatoid and other disease histology, respectively. PD-L1 status was negative, positive, not applicable and missing in 16.3%, 5.8%, 28.8% and 49% of patients, respectively. Prior anticancer treatments included adjuvant drug treatment (3.8%), surgery (75%), nephrectomy (66.3%) and radiotherapy (8.7%). At baseline, the median time since initial diagnosis was 0.7 years.

At the last follow-up, 20% of patients were still receiving Bavencio or Inlyta, 20% of patients had discontinued treatment and remained in follow-up, and 60% of patients had discontinued from the study. Reasons for study discontinuation included death (38.1%), completion of the study (28.6%), and loss to follow-up (15.9%).

The median duration of Bavencio treatment was 341 days, and the median duration of Inlyta treatment was 354 days. The median time to discontinuation of both Inlyta and Bavencio was 208 days.

Subgroup analyses of 12-month OS rates showed that among patients younger than 65 years of age, 65 to 75 years of age, and older than 75 years of age, the 12-month OS rates were 85.5%, 84.5% and 75.8%, respectively. Among patients with an ECOG performance status of 0/1 or 2, these rates were 84.3% and 57.1%, respectively. Among patients from Belgium, Germany, Greece and Russia, these respective rates were 87.5%, 86.2%, 71.9% and 95.2%.

Among patients with IMDC favorable-, intermediate-, and poor-risk disease, the 12-month OS rates were 92.6%, 74.1% and 82.5%, respectively. Among patients with clear cell, sarcomatoid, and other histologies, these respective rates were 83.1%, 100% and 66.7%. Patients who had undergone prior nephrectomy (69 patients) had a 12-month OS rate of 86.7% versus 73.4% among those who had not undergone prior nephrectomy (35 patients).

In the overall population, the median PFS was 11.3 months. The six- and 12-month PFS rates were 72.5% and 48.4%, respectively.

Among 87 response-evaluable patients, the ORR was 46%, including complete response (CR), partial response, stable disease, progressive disease (PD), and non-CR/non-PD rates of 4.6%, 41.4%, 31%, 20.7% and 2.3%, respectively. The DCR was 79.3% and the median DOR was NR.

“Real-world effectiveness and safety of first-line (1L) avelumab + axitinib in patients with advanced renal cell carcinoma (aRCC): primary analysis of the AVION study.” by Dr. Merseburger A, et al., 

“Avelumab + axitinib versus sunitinib in patients (pts) with advanced renal cell carcinoma (aRCC): final overall survival (OS) analysis from the JAVELIN Renal 101 phase 3 trial.” by Dr. Motzer RJ, et al., 

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Articles

The combination of Bavencio (avelumab) and Inlyta (axitinib) has shown effectiveness and safety in treating advanced renal cell carcinoma (RCC) in a real-world setting, consistent with previous clinical trials. The AVION study reported a six-month overall survival (OS) rate of 89.1% and a 12-month OS rate of 82.7%. Adverse events (AEs) were common, with 83.7% experiencing any-grade AEs and 34.6% experiencing severe AEs. The study highlighted the combination's favorable tolerability and stable health-related quality of life (HRQOL) in a diverse patient population.

In a real-world analysis of patients with advanced RCC, the combination of first-line Bavencio and Inlyta was effective and safe.

Real-World Data Confirms Safety of Bavencio and Inlyta in Advanced RCC

In patients with low-grade, intermediate-risk NMIBC, UGN-102 generated robust, durable responses. © stock.adobe.com.

For patients with low-grade, intermediate-risk non-muscle-invasive bladder cancer (NMIBC), UGN-102 generated robust and durable responses in an analysis of the phase 3 ENVISION and ATLAS studies, according to findings that were presented at the 

Complete response: disappearance of all detectable disease following treatment.

Transurethral resection of bladder tumor (TURBT): surgical procedure to remove bladder tumors via the urethra.

Kaplan-Meier estimate: statistical method to estimate survival probabilities over time.

Micturition urgency: sudden, strong need to urinate.

Pollakiuria: abnormally frequent urination.

Urethral stenosis: narrowing of the urethra, leading to urinary obstruction.

Malaise: general feeling of discomfort or unease.

Disease-free survival (DFS): time from treatment to disease recurrence or death.

Duration of response (DOR): length of time a tumor responds to treatment without progression.

Mitomycin-containing reverse thermal hydrogel: temperature-sensitive gel that delivers mitomycin intravesically for bladder cancer treatment.

Intravesical treatment with UGN-102: non-surgical therapy using a mitomycin-based reverse thermal gel for low-grade bladder cancer.

In the single-arm ENVISION trial, 79.6% of patients with recurrent disease who received UGN-102 (240 patients) achieved a complete response (CR) at three months, and the estimated 12-month CR rate was 82.3%.

In the randomized ATLAS trial, 64.8% of patients with newly diagnosed or recurrent disease who received UGN-102 with or without subsequent transurethral resection of bladder tumor (TURBT; 142 patients) achieved a CR at three months versus 63.6% of those who underwent TURBT (140 patients). The Kaplan-Meier estimated 12-month CR rates in these respective arms were 79.7% and 67.7%.

“These results demonstrate that treatment with UGN-102 results in a high and clinically meaningful durable CR rate in patients with newly diagnosed or recurrent low-grade, intermediate-risk NMIBC,” lead study author Dr. Sandip M. Prasad, of Morristown Medical Center, Atlantic Medical Group, in New Jersey and coauthors wrote in a poster presentation of the data.

The most common side effect observed with UGN-102 across both trials was dysuria, which was reported in 22.5% and 30.4% of patients who received the UGN-102 in ENVISION and ATLAS, respectively.

Previously reported safety findings from ENVISION showed that additional treatment-emergent side effects with UGN-102 included hematuria (8.3%), urinary tract infection (7.1%), pollakiuria (6.7%), fatigue (5.4%), urinary retention (5%), urethral stenosis (4.6%), COVID-19 (3.8%), constipation (3.8%), nausea (3.8%) and micturition urgency (3.3%).

Previously reported safety findings from ATLAS demonstrated that additional treatment-emergent side effects in the UGN-102 and TURBT arms, respectively, included micturition urgency (18%; 7.6%), nocturia (18%; 6.8%), pollakiuria (16%; 6.1%), flatulence (9.4%; 3%), COVID-19 (8.0%; 6.1%), erectile dysfunction (6.5%; 3%), hematuria (6.5%; 4.5%) and malaise (5.8%; 1.5%).

“UGN-102 may represent an efficacious and well-tolerated treatment option for patients with low-grade, intermediate-risk NMIBC,” the authors wrote in the poster.

Among the patients in the ENVISION and ATLAS trials, respectively, 68% and 60% were at least 65 years of age; 98% and 99% were White; and 61% and 70% were male.

The median duration of response (DOR) was not estimable in any of the 3 trial arms because of low recurrence rates. In ENVISION, at a median follow up for DOR of 13.86 months, 17.3% of complete responders (191 patients) had disease recurrence, including low-grade disease (14.1%) and high-grade disease (2.1%). Two patients had died.

In the UGN-102 arm, at a median follow-up for DOR of 12.45 months, 19.6% of complete responders (92 patients) had disease recurrence, including low-grade disease (16.3%) and high-grade disease (3.3%). No patients in this arm had died. In the TURBT arm, at a median follow-up for DOR of 12.16 months, 27% of complete responders (89 patients) had disease recurrence, including low-grade disease (19.1%) and high-grade disease (6.7%). One patient in this arm had died.

TURBT is the current standard of care (SOC) for patients with low-grade, intermediate-risk NMIBC; however, the study authors noted that this treatment method provides inadequate disease control and that patients often need to undergo multiple TURBTs under general anesthesia, which has associated complications, particularly for elderly patients. To address this need, the ENVISION and ATLAS trials studied the efficacy of intravesical treatment with UGN-102, a mitomycin-containing reverse thermal hydrogel, in patients with low-grade, intermediate-risk NMIBC.

In both studies, patients in the UGN-102 arms received UGN-102 via a urinary catheter at 75 milligrams once weekly for six months. In ENVISION, patients with recurrent disease received UGN-102, and those without a CR at three months subsequently received SOC treatment and entered the follow-up period. In ATLAS, patients with newly diagnosed or recurrent disease were randomly assigned to receive UGN-102 or TURBT. Those without a CR with residual low-grade disease subsequently received TURBT and entered the follow-up period. All patients in both trials were examined for bladder cancer recurrence using cystoscopy, urine cytology and for-cause biopsy at three months and at regular intervals thereafter.

In ENVISION, the primary end point was CR at three months. In ATLAS, the primary end point was disease-free survival (DFS). Secondary end points in both trials included DOR and safety.

showed that UGN-102 with or without TURBT generated similar estimated DFS outcomes for patients with newly diagnosed versus recurrent disease. The estimated 15-month DFS rate with UGN-102 was 77.4% in patients with newly diagnosed disease versus 63.2% in those with recurrent disease.

“Treatment of Low-Grade Intermediate-Risk Non-Muscle-Invasive Bladder Cancer With UGN-102: Results of the Phase 3 ATLAS and ENVISION Studies” by Dr. Prasad S, et al., 

“Response to Primary Chemoablation With UGN-102 in Patients With New or Recurrent LG IR NMIBC: Post-Hoc Analysis of the ATLAS Trial” by Dr. Prasad SM, et al., 

“Primary Chemoablation of Recurrent Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer With UGN-102: A Single-Arm, Open-Label, Phase 3 Trial (ENVISION)” by Dr. Prasad SM, et al., 

“Treatment of Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer With UGN-102 ± Transurethral Resection of Bladder Tumor Compared to Transurethral Resection of Bladder Tumor Monotherapy: A Randomized, Controlled, Phase 3 Trial (ATLAS)” by Dr. Prasad SM, et al., 

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UGN-102 demonstrated significant efficacy in treating low-grade, intermediate-risk non-muscle-invasive bladder cancer (NMIBC) in the phase 3 ENVISION and ATLAS trials. In the ENVISION trial, 79.6% of patients achieved a complete response (CR) at three months, with a 12-month CR rate of 82.3%. The ATLAS trial showed similar results, with 64.8% achieving CR at three months. UGN-102 was generally well-tolerated, with dysuria being the most common side effect. The trials suggest UGN-102 as a promising alternative to transurethral resection of bladder tumor (TURBT) for NMIBC management.

Among patients with low-grade, intermediate-risk NMIBC, UGN-102 generated robust, durable responses in an analysis of the phase 3 ENVISION and ATLAS studies.

UGN-102 Shows Complete Response Rates in Low-Grade Bladder Cancer

Lonsurf showed a numerical but not significant improvement in disease-free survival over placebo in patients with resected stage 4 colorectal cancer.

Among the full population of patients with colorectal cancer (CRC) who had molecular residual disease after curative resection who were enrolled to the phase 3 ALTAIR study, Lonsurf (trifluridine/tipiracil) did not result in significant improvement in disease-free survival (DFS) over treatment with a placebo, but showed benefit in patients with stage 4 disease.

Findings, which were shared during the 2025 Gastrointestinal Cancers Symposium, showed that in all patients, the median DFS with Lonsurf (122 patients) was 9.3 months versus 5.55 months with placebo (121 patients), which translated to a numerical but not statistically significant improvement with Lonsurf. Moreover, in the Lonsurf arm, the DFS rates at six, 12, 18 and 24 months were 70.5%, 31.8%, 20.8% and 16.9%, respectively; in the placebo arm, these respective rates were 45.5%, 26.8%, 21.5% and 14.5%.

In the subgroup of patients with stage 4 disease, the benefit of Lonsurf (34 patients) was reported to be highly pronounced versus placebo (32 patients), with a median DFS of 9.76 months and 3.96 months, respectively. In the Lonsurf arm, the six-, 12-, 18- and 14-month DFS rates were 70.47%, 27.57%, 9.19% and 4.6%, respectively; in the placebo arm, these respective rates were 31.25%, 12.5%, 3.12% and not reached.

“Overall survival data were immature, with only 24 events observed across both arms,” lead study author Dr. Hideaki Bando of the Department of Gastrointestinal Oncology at the National Cancer Center Hospital East in Kashiwa, Japan, and colleagues, wrote in a late-breaking poster spotlighting the data.

Disease-free survival (DFS): time without cancer after treatment.

Overall survival: percentage of patients alive after treatment.

Metastasis: spread of cancer to other body parts.

Microsatellite-stable disease: no defects in DNA microsatellites.

Molecular residual disease: trace cancer cells detected after remission.

Curative resection: surgery to remove all tumor tissue for cure.

Circulating tumor DNA (ctDNA): tumor DNA found in the blood.

 which are biomarkers used to measure tumor presence or response to treatment in blood.

“Baseline characteristics were balanced between the two groups, and 96.3% of patients received standard-of-care treatment before enrollment,” the study authors wrote. In all patients, 64% were younger than 70 years, 58% were male, 71% had left-sided colon as their primary tumor site and 45% had stage 3 disease. Thirty-six percent received neoadjuvant treatment, and 46% received adjuvant treatment. At one-month post-operation, 53% tested positive for circulating tumor DNA (ctDNA). Most patients had BRAF wild-type disease (96%), and 61% had RAS wild-type disease (61%). Ninety-eight percent of patients had microsatellite-stable disease.

Additional efficacy findings were reported for patients with non-stage 4 disease. In this group, the median DFS with Lonsurf was 9.26 months versus 6.05 months with placebo.

Moreover, the baseline MTM/mL levels proved to be significantly higher in patients with stage 4 disease versus non-stage 4 disease (0.68 versus 0.32). “The [Lonsurf] benefit was significantly pronounced with higher MTM/mL, with linear benefit observed with increasing MTM/mL values at the enrollment time point,” the study authors underscored in the abstract.

Regarding safety, any-grade side effects occurred in 98.4% of patients in the Lonsurf arm versus 57% of those in the placebo arm; these effects were grade 3 (severe) or worse for 73% and 3.3% of patients, respectively. Serious side effects were experienced by 4.9% of those in the Lonsurf arm; none occurred in the placebo arm. Side effects led to discontinuation for 6.6% of patients in the Lonsurf arm. No side effects proved to be fatal in either arm.

Any-grade side effects related to Lonsurf or placebo occurred in 98.4% and 33.1% of patients, respectively; they were grade 3 or worse for 71.3% and 0.8% of patients, respectively. Only one serious treatment-related side effect was reported in the Lonsurf arm, and five treatment-related side effects led to discontinuation in this arm.

“No new safety signals were identified,” the study authors wrote.

Testing ctDNA for molecular residual disease has proven to serve as a strong predictor for CRC recurrence, although the effectiveness of starting systemic treatment to prevent or delay recurrence in patients with molecular disease after curative surgery remains an open question. With ALTAIR, investigators sought to determine the clinical relevance of leveraging Lonsurf as a pre-emptive therapy for patients who were enrolled to the CIRCULATE-Japan study and who had positive ctDNA following curative resection.

ALTAIR enrolled patients with CRC who received curative resection of primary and/or metastatic sites with or without standard adjuvant treatment and who prospectively tested ctNDA positive per the Signatera assay within three months before enrollment and did not experience recurrence per CT imaging.

Patients were then randomly assigned to receive either Lonsurf or placebo for the duration of six months. Investigators performed CT and ctDNA analyses every two months for the first year and every three months for the second year, followed by additional CT analyses every six months for the third year. DFS served as the primary end point of the study.

Of the 243 patients who were registered in the trial, 122 were included in the Lonsurf arm, and 121 were included in the placebo arm; 72 and 59 patients, respectively, discontinued. In the Lonsurf arm, the most common reason for discontinuation was primary disease relapse (34 patients), followed by side effect (eight patients) and the planned start date of the second course being set as the first day of treatment and the start of the next course being delayed beyond the same day of the week, four weeks later (eight patients).

“A randomized, double-blind, phase III study comparing trifluridine/tipiracil (FTD/TPI) versus placebo in patients with molecular residual disease following curative resection of colorectal cancer (CRC): the ALTAIR study.” By Dr. Dr. Hideaki Bando, et al. 

Lonsurf (trifluridine/tipiracil) did not significantly improve disease-free survival (DFS) over placebo in colorectal cancer patients with molecular residual disease post-curative resection, except in stage 4 patients. The ALTAIR study showed a median DFS of 9.3 months with Lonsurf versus 5.55 months with placebo, but this was not statistically significant. Stage 4 patients showed a pronounced benefit with Lonsurf. Safety analysis revealed high rates of side effects with Lonsurf, though no new safety signals were identified. The study highlights the potential of ctDNA as a predictor for CRC recurrence.

In patients with residual disease after curative resection of colorectal cancer, Lonsurf showed a numerical improvement in DFS, though not significant.

Lonsurf Shows Survival Benefit Over Placebo in Stage 4 Colorectal Cancer

Early and late responders with ESCC experienced comparable OS benefits with Tevimbra plus chemo.

Patients with locally advanced, unresectable or metastatic esophageal squamous cell carcinoma (ESCC) who responded to first-line Tevimbra (tislelizumab) plus chemotherapy showed improved overall survival (OS) with deeper responses and a longer time to maximum response, according to data from the phase 3 RATIONALE-306 study presented at the 

2025 ASCO Gastrointestinal Cancers Symposium.

As of November 24, 2023, 68.3% (207 patients) of patients in the intention-to-treat population who received Tevimbra plus chemotherapy achieved a response, with a median time to response of 6.1 weeks. Most responses (64.7%) were achieved within eight weeks of treatment; 22.2% of responses were achieved after eight weeks, up to and including 14 weeks; and 13% of responses were achieved after 14 weeks.

Overall survival: the time from diagnosis or treatment initiation when a patient with cancer is still alive.

Time to maximum response: time it takes for a patient’s tumor to reach the greatest degree of shrinkage or response to treatment.

Intention-to-treat population: a group of patients who were randomly assigned to receive a particular treatment, whether or not they actually received that treatment or adhered to it.

Depth of response rate: how much a tumor shrinks in response to therapy.

ECOG performance status of 0 or 1: a tool used by clinicians to assess a patient’s overall health and ability to perform daily activities. A status of 0 indicates that a patient is fully active and has no restrictions. With a status of 1, a patient is restricted in strenuous physical activity but is able to carry out light housework or sedentary activities.

Overall response rate: the percentage of patients whose cancer shrinks or disappears entirely after treatment.

PD-L1 tumor area positivity score of 10% or greater: at least 10% of the tumor area of covered by PD-L1-positive cells, which are proteins found on some cancer cells that helps cancer cells evade the immune system.

For patients in these three time-to-response groups, the median OS was 21.8 months, 23.1 months and 29 months, respectively. The median OS after first response in these respective groups were 21.3 months, 21.3 months and 23.2 months.

“In the [Tevimbra] plus chemotherapy arm, 64.7% of responders achieved a response within eight weeks, while still 35.2% of responders achieved response at later assessments,” lead study author Dr. Yi Li, of Fifth Medical Center, Chinese PLA General Hospital in Beijing, China, and colleagues wrote in a poster presentation of the data. “[However,] the [OS] benefits were comparable between early responders and late responders.”

The depth of response rate among responders to Tevimbra plus chemotherapy was 62.1%. Over half (50.2%) of responders achieved a depth of response above 50% up to and including 80%; a depth of response above 30% up to and including 50% was observed in 29.8% of responders; and a depth of response greater than 80% up to and including 100% was observed in 20% of responders. Among these three depth-of-response groups, the median OS was 23.7 months, 16.1 months and 34.5 months, respectively.

Among responders, the median time to maximum response was 19 weeks. Maximum response was achieved within 14 weeks, after 14 weeks up to and including 28 weeks, and after 28 weeks in 32.7%, 34.6% and 32.7% of responders, respectively. The median OS for patients in these respective time to maximum response categories was 14.3 months, 17.4 months and 39.9 months. The median OS after maximum response was 12.6 months, 14.3 months and 24.8 months, respectively.

RATIONALE-306 was a trial that enrolled patients at least 18 years of age with unresectable locally advanced or metastatic ESCC, no prior systemic treatment for advanced disease, an ECOG performance status of 0 or 1, and measurable or evaluable disease. Upon enrollment, patients were randomly assigned to receive Tevimbra or placebo intravenously once every three weeks alongside chemotherapy. Treatment continued until disease progression or unacceptable toxicity.

The study’s primary end point was OS in the intention-to-treat patient population. Key secondary end points included progression-free survival, overall response rate, duration of response, OS in patients with a PD-L1 tumor area positivity score of 10% or greater, and safety. Notably, tumor response was assessed every six weeks for the first 48 weeks and every nine weeks thereafter.

Disclosures: Dr Li has no relationships to disclose.

Response characteristics of tislelizumab (TIS) plus chemotherapy (chemo) in first-line (1L) treatment of locally advanced or metastatic esophageal squamous cell carcinoma (ESCC): a post hoc analysis of RATIONALE-306. Dr Yi Li, et al. 

Patients with locally advanced, unresectable, or metastatic esophageal squamous cell carcinoma (ESCC) showed improved overall survival (OS) when treated with Tevimbra (tislelizumab) plus chemotherapy, as per the phase 3 RATIONALE-306 study. The study revealed that 68.3% of patients achieved a response, with a median time to response of 6.1 weeks. The depth of response and time to maximum response were significant factors influencing OS. The trial's primary endpoint was OS, with secondary endpoints including progression-free survival and overall response rate.

Early and late responders with esophageal squamous cell carcinoma experienced comparable OS benefits with Tevimbra plus chemo in the RATIONALE-306 trial.

Ashling Wahner

Real-World Data Confirms Safety of Bavencio and Inlyta in Advanced RCC

UGN-102 Shows Complete Response Rates in Low-Grade Bladder Cancer

Lonsurf Shows Survival Benefit Over Placebo in Stage 4 Colorectal Cancer

Tevimbra Plus Chemotherapy May Improve Survival in First-Line ESCC

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