Kristi Rosa

Adding Tecentriq (atezolizumab) to chemotherapy did not improve survival compared to chemotherapy alone in patients with triple-negative breast cancer (TNBC) whose disease relapsed within a year of their last treatment for early breast cancer, according to findings from the phase 3 IMpassion132 clinical trial.

Findings from the study were presented at the 2024 ESMO Breast Cancer Congress.

The addition of Tecentriq did not improve survival compared to chemotherapy alone in patients with triple-negative breast cancer.

The median overall survival was 11.2 months with chemotherapy alone and 12.1 months with Tecentriq plus chemotherapy, so the researchers could not say for certain that one treatment was better than the other.

More research is needed to develop new therapies for this group of patients.

Doctors need to consider the different types of TNBC when making treatment decisions.

At a median follow-up of 9.8 months, the median overall survival (OS; time patients live before death of any cause) was 11.2 months with chemotherapy alone (177 patients) compared to 12.1 months with Tecentriq plus chemotherapy (177 patients) in patients with PD-L1–positive TNBC. Of note, PD-L1 is the protein that Tecentriq targets to help activate the immune system against the cancer.

The difference between these two OS outcomes was not statistically significant, meaning that the researchers could not say with certainty that one regimen was better than the other.

Although not formally, these results were consistent in the modified study population, with a median OS of 9.8 months with chemotherapy alone (192 patients) compared to 10.4 months with Tecentriq plus chemotherapy (188 patients). Again, the difference between the two OS outcomes was not statistically significant.

“Novel therapies and trial designs are urgently required for this treatment-resistant population and these data highlight the importance of recognizing, as we have before, that TNBC is highly heterogeneous — especially in the first-line setting,” Dr. Rebecca A. Dent, of the National Cancer Center Singapore and Duke-NUS Medical School, in Singapore, said in a presentation of the data. “We now recognize that PD-L1­–positive and ­negative patients have a very different prognosis. We’ve also realized that patients who harbor 

mutations also have a different prognosis, and we know that patients who have de novo metastatic TNBC [meaning the disease has already spread at the time of diagnosis] also clearly have a different prognosis than those who have received neoadjuvant therapy and were exposed to a number of agents by the time they reach their first-line status. As we are here discussing novel trial designs for early-relapsing TNBC, I really think we need to take this into account.”

About half of patients who develop metastatic TNBC after standard presurgical or postsurgical chemotherapy will relapse within one year of chemotherapy completion. Early relapsing TNBC represents a biologically and clinically distinct entity in that it is typically resistant to standard options and is more prevalent in younger patients who have large primary tumors that do not harbor 

Notably, the majority of clinical trials do not include those patients, which “poses a real challenge for us in clinical practice,” she underscored.

The phase 3 IMpassion132 trial enrolled patients with unresectable locally advanced or metastatic TNBC who previously received an anthracycline and taxane for early disease and experienced progressive disease within one year after their last curative-intent treatment. They could not have previously received chemotherapy for advanced disease, and their PD-L1 status needed to be available.

Participants were randomly assigned to investigator-selected chemotherapy in the form of gemcitabine plus carboplatin or capecitabine with or without Tecentriq. Treatment continued until progressive disease or intolerable side effects.

OS served as the trial’s main goal. Patients who were PD-L1­ positive were evaluated, and if positive, modified.

“In August of 2019, we saw the results of the IMpassion130 study, which clearly showed us that the benefits of immune checkpoint inhibition were largely driven by those patients who had PD-L1–positive metastatic TNBC, which is similar to what we’ve observed in the KEYNOTE-355 study using [Keytruda (pembrolizumab)],” Dent said.

The primary analysis was planned when a prespecified number of 247 deaths occurred in the PD-L1–positive subgroup. If positive, investigators would then look at the modified population, which included patients irrespective of PD-L1 status.

The median patient age was 48 years in the chemotherapy-alone and Tecentriq groups, respectively. Slightly more than half of patients had an ECOG performance status of 0 (57% versus 62%), indicating that they could perform all their daily tasks with no difficulty or assistance. Eighteen percent in both arms had prior exposure to platinum-based chemotherapy; 27% and 29% of patients, respectively previously received capecitabine. More than half of patients were without complications or recurrence of their disease for less than six months (69% versus 66%) and had lung and/or liver metastases (62% versus 60%). Investigator-selected chemotherapy was carboplatin/gemcitabine for 73% and capecitabine for 27% of those in both arms.

“What you can see is in those patients, and remember, this is about three-quarters of the patients who had a [disease-free interval] of less than six months, the median OS was only 9.4 months in the control arm and 11.3 months in the [Tecentriq] arm. But you can see in both of these subgroups, whether they relapsed less than six months or greater than six months, there was no statistically significant improvement in OS with the addition of Tecentriq.”

The median progression-free survival (PFS; time after treatment patients live without their disease worsening) in the chemotherapy-only arm was 3.6 months versus 4.2 months in the Tecentriq arm.

The unconfirmed objective response rates (percentage of patients whose disease shrunk or disappeared) in the respective arms were 28% and 40% respectively, translating to a percentage difference of 11%.

The median duration of response in the placebo arm was 4.1 months versus 6.6 months in the Tecentriq arm. Data for these secondary end points in the modified population proved to be consistent, according to Dent.

Safety was evaluated in a total of 587 patients (294 in the chemotherapy-only group and 293 in the Tecentriq group). A side effect of any severity occurred in 96% of those in the placebo arm and 96% in the Tecentriq arm; these effects were treatment related for 91% and 90% of patients, respectively. Treatment-related grade 3 or 4 side effects (meaning that they were moderate to severe) occurred in 71% and 67% of patients, respectively, and were grade 3 or 4 for 65% and 62% of patients, respectively.

Two patients in the chemotherapy-only arm experienced a treatment-related death, while four patients in the Tecentriq arm died, only one of which was determined to be treatment related. Side effects of special interest occurred in 54% and 61% of patients, respectively. Side effects led to treatment discontinuation for 11% of those in the placebo arm and 15% of those in the Tecentriq arm.

“No new safety signals were observed,” Dent concluded.

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Articles

The addition of Tecentriq to chemotherapy did not improve overall survival in patients with relapsed triple-negative breast cancer. 

Adding Tecentriq to Chemo Did Not Boost TNBC Survival

Patients with advanced urothelial carcinoma, a type of bladder cancer, some of whom were ineligible for cisplatin, who were treated with frontline Keytruda (pembrolizumab) and Cabometyx (cabozantinib) responded to treatment with a manageable side effect profile, recent study results demonstrated.

These findings from the phase 2 PemCab trial were presented at the 

The doublet elicited an objective response rate (the percentage of patients with a complete or partial response to treatment) of 45.7% in evaluable patients (36 patients), which was comprised of a complete response (disappearance of all signs of cancer from treatment) rate of 14.2% and a partial response (decrease in tumor size or extent of cancer in the body from treatment) rate of 31.4%; 25.7% of patients had a best response of stable disease (cancer that is neither increasing or decreasing in severity or extent), 28.5% experienced disease progression (cancer that continues to spread or grow) and one patient was not evaluable. The clinical benefit rate (percentage of patients who achieve partial remission, partial remission or stable disease for six months) was 71.4% with the regimen, and 80% of patients experienced tumor shrinkage.

A combination treatment using Keytruda (pembrolizumab) and Cabometyx (cabozantinib) has shown effectiveness and manageable side effects for patients with advanced urothelial carcinoma, even for those ineligible for cisplatin treatment.

The treatment resulted in a positive response rate, with a substantial number of patients experiencing either complete disappearance or a significant reduction in their disease.

Patients receiving Keytruda and Cabometyx experienced tumor shrinkage, and the median duration of response was notable, suggesting a meaningful impact on controlling the progression of the disease.

The study addressed an unmet need for patients with limited therapeutic options, especially those ineligible for cisplatin, providing a potential alternative with manageable side effects and promising efficacy.

The median time to response was 2.7 months, and at a median follow-up of 20.2 months, the median duration of response (the time from treatment assignment until progression or death in those who achieved a partial or complete response) was 14.7 months. As of their last follow-up in the clinic, eight patients were still responding to treatment. At a median follow-up of 14.3 months, the median progression-free survival (the time during and after treatment when a patient lives with the disease without worsening) was 7.6 months, and the median overall survival (the time from the start of treatment when a patient with cancer is still alive) was 17.1 months.

“In this hard-to-treat population consisting of cisplatin-ineligible with high PD-L1 score (meaning they are eligible for immunotherapy), cisplatin-refusing and platinum-ineligible patients (with urothelial carcinoma, Cabometyx) plus (Keytruda) showed encouraging efficacy,” said Dr. Rohit K. Jain, assistant member in the Department of Genitourinary Oncology at Moffitt Cancer Center in Tampa, Florida, in a presentation of the data.

There are limited therapeutic options available to patients with cisplatin- and platinum-ineligible locally advanced or metastatic urothelial carcinoma, underscoring an area of unmet need. VEGFR TKIs like Cabometyx, Votrient (pazopanib) and Sutent (sunitinib) have exhibited response rates ranging from 7% to 19% in patients with pretreated metastatic urothelial carcinoma, according to Jain. He added that although phase 3 trial data have indicated that regimens like Avastin (bevacizumab) paired with cisplatin and gemcitabine and Cyramza (ramucirumab) plus docetaxel can prolong progression-free survival, they have not led to significant improvements in overall survival.

The study enrolled patients with locally advanced or metastatic urothelial carcinoma who had an ECOG performance status of 0 to 2 (meaning patients who were either fully active up to being restricted in work activity but able to perform self-care tasks) and a measurable target lesion. Patients also needed to have cisplatin-ineligible disease.

Study participants were given Keytruda every 3 weeks plus daily Cabometyx until disease progression, intolerable side effects or for up to two years.

The main focus of the study was to assess the objective response rate, with other areas including progression-free survival, overall survival, duration of response, disease control rate (patients with partial response, complete response or stable disease from treatment) and safety.

Between December 2018 and April 2023, a total of 36 patients were enrolled in the phase 2 study. The median patient age was 72.5 years, and most patients were male (77.8%). Regarding primary tumor location, 52.8% had upper tract disease and 47.2% had disease in the bladder.

At the time of data cutoff in November 2023, one patient was still on treatment. The most common reason for discontinuation was radiological or clinical disease progression (50%), followed by side effects (22.2%), patient decision (13.8%), death because of disease progression (5.5%) and treatment completion (5.5%). The median number of cycles of Keytruda and Cabometyx received was 10 and 7.5, respectively.

No new safety signals were observed with the doublet. Most patients (91.6%) experienced at least one treatment-emergent side effect and 50% had side effects that were severe or worse. Two instances of life-threatening side effects related to Cabometyx were observed; these effects included gastrointestinal bleeding and colonic perforation (a hole in the wall of the colon or small intestine). Moreover, 83% of patients had immune-related side effects with 11% needing high-dose steroids. There were no treatment-related deaths.

Cabometyx dose interruptions and reductions were needed in 47.2% and 33.3% of patients, respectively; 16.6% of patients discontinued the agent.

The most common treatment-emergent side effects reported with Cabometyx plus Keytruda were fatigue (any severity, 63.9%; severe or worse, 2.8%), diarrhea (58.3%; 2.8%), palmar-plantar erythrodysesthesia syndrome (also known as hand-foot syndrome when patients develop swelling, redness and pain on their hands and feet; 41.7%; 5.6%), itching (38.9%; 0%), anorexia (33.3%; 5.6%), nausea (33.3%; 2.8%), low phosphate levels in the blood (27.8%; 0%), low magnesium levels in blood (25%; 0%), hypothyroidism (underactive thyroid; 25%; 0%), oral mucositis (irritation and tissue swelling in the mouth; 25%; 2.8%), vomiting (25%; 0%), hoarseness (22.2%; 0%), elevated protein in the urine (13.9%; 5.6%) and a thromboembolic event (related to blood clots; 8.3%; 8.3%).

Frontline treatment with Keytruda and Cabometyx produced responses with a manageable safety profile in patients with cisplatin-ineligible urothelial carcinoma, a type of bladder cancer.

Keytruda Plus Cabometyx Produces Responses in Cisplatin-Ineligible Bladder Cancer

Adding Imfinzi (durvalumab) to a standard presurgical chemotherapy regimen improved pathologic complete response (pCR; disappearance of cancer) compared to chemotherapy alone in patients with resectable, early-stage, locally advanced gastric and gastroesophageal junction (GEJ) cancers, regardless of where they are located, according to a subgroup analysis from the phase 3 MATTERHORN trial.

Prior findings from an interim analysis showed that Imfinzi plus the chemotherapy regimen known as FLOT (made up of 5-fluorouracil [5-FU], leucovorin, oxaliplatin and docetaxel), which was given to a group of 474 patients, elicited a pCR rate of 19% compared with 7% with placebo plus FLOT, given to another group of 474 patients, meeting a secondary endpoint of the trial.The Imfinzi regimen also improved combined complete and near-complete pathological response versus placebo plus FLOT, at 27% and 14%, respectively.

 demonstrated a consistent pCR improvement with the addition of Imfinzi to FLOT versus FLOT alone when broken down by region.Those in Asia who received Imfinzi plus FLOT (90 patients) achieved a pCR of 19% versus 6% with placebo plus FLOT (90 patients). Those in the non-Asia group who received Imfinzi/FLOT (384 patients) experienced a pCR of 19% versus 8% for those given placebo/FLOT (384 patients).

When the non-Asia subgroup was broken down further into countries, those in Europe (506 patients) who received Imfinzi plus FLOT (256 patients) achieved a pCR of 18% versus 8% with placebo plus FLOT (250 patients). Within the North American subgroup (82 patients), Imfinzi plus FLOT (42 patients) led to a pCR of 29% versus 8% with placebo plus FLOT (40 patients). In the South America subgroup (180 patients), the pCRs were achieved with Imfinzi/FLOT (86 patients) and placebo/FLOT (94 patients), at 17% and 5%, respectively.

Adding Imfinzi to standard presurgical chemotherapy (FLOT regimen) significantly improved the rate of patients who experienced a disappearance of cancer in patients with resectable, early-stage gastric and gastroesophageal junction cancers compared to chemotherapy alone, according to the phase 3 MATTERHORN trial.

The study demonstrated a consistent improvement in pathologic complete response across different regions.

The trial successfully delivered FLOT globally, and the addition of Imfinzi to FLOT was feasible. The study indicated good exposure to FLOT, with a high percentage of patients receiving preoperative and adjuvant FLOT. The delivery of FLOT was found to be feasible across different regions.

Further data on event-free survival and progression-free survival is awaited.

“MATTERHORN is the first global phase 3 study that successfully randomized patients to receive perioperative FLOT globally in gastric and gastroesophageal adenocarcinoma (with) placebo (or) (Imfinzi) and we demonstrated that the addition of (Imfinzi) to perioperative FLOT showed consistent improvement in pCR vs placebo across the globe,” Dr. Yelena Janjigian, chief of the Gastrointestinal Oncology Service at Memorial Sloan Kettering Cancer Center, said in a presentation during the meeting. “We (also) saw benefit in microsatellite instability-high (MSI-H) and non-MSI-H subgroups.”

For patients with operable gastric or GEJ cancer, perioperative treatment with FLOT is the standard of care based on findings from the phase 2/3 FLOT-4 trial; however, global data on this chemotherapy regimen, Janjigian noted. For those with metastatic disease, standard treatment generally consists of PD-1 blockade paired with chemotherapy, she added.

The global, double-blind, placebo-controlled MATTERHORN study enrolled patients from Asia, Europe, North America and South America who had stage 2, 3 and 4A gastric or GEJ adenocarcinoma and an ECOG performance status of 0 or 1, indicating that they could perform all or most of their daily tasks independently. Patients could not have evidence of metastasis, nor could they have received prior treatment.

A total of 948 participants were randomly assigned to the Imfinzi or placebo group. After the treatment, patients then underwent surgery and received two doses of Imfinzi or placebo plus four doses of FLOT, followed by Imfinzi or placebo monotherapy given on day 1 every four weeks for 10 further cycles.

“They received up to one year of total adjuvant therapy,” Janjigian said.

Randomization was stratified by geographic region (Asia vs non-Asia), clinical lymph node status (positive versus negative), and PD-L1 status (tumor area positivity [TAP] <1% versus TAP ≥1%).

The trial’s main goal point is event-free survival (EFS; time a patient lives without complications from cancer or disease worsening), and key secondary endpoints include pCR by central review and modified Ryan criteria and overall survival.

“This was truly a global study and the first of its kind to be able to deliver FLOT to the Asian continent,” Janjigian explained. Nineteen percent of patients were treated in Asia and 19% in South America. “The predominant patient population were in Europe (53%,) where FLOT is the most used and common regimen,” she added. Nine percent of patients received treatment in North America.

Baseline characteristics were “well matched” across the Imfinzi and placebo treatment arms, Janjigian said. The median age was 62.5 years (range, 26-84), and most patients were male (69% versus 75%) and had an ECOG performance status of 0 (71% vs 77%). More than half of patients had gastric cancer (68% versus 67%) and the remainder had GEJ cancer (32% versus 33%). Most patients had a disease that grew through the connective tissue of the stomach (65% versus 68%), positive clinical lymph nodes (69% versus 70%), and non-MSI-H disease (92% versus 93%). Moreover, patients had intestinal histology (37% versus 35%), diffuse histology (22% versus 18%) or an unspecified adenocarcinoma or other (41% versus 47%).

In the Imfinzi arm, 10% had a PD-L1 tumor area positivity (TAP) of less than 1%, 90% had a TAP of 1% or higher, 50% had a TAP of less than 5%, 50% had a TAP of 5% or higher, 78% had a TAP of less than 10%, and 22% had a TAP of 10% or higher; these rates were 10%, 90%, 49%, 51%, 79% and 21%, respectively, in the placebo arm.

“Across the exploratory analysis for the subgroups, you can see the OR favor the addition of (Imfinzi) essentially across all subgroups,” Janjigian said. “The MSI-H subgroup is very rare so there’s a very wide confidence interval. Also, there were very few patients with a TAP of less than 1% expression, so also a very wide range.”

At the time of the data cutoff, 45% of patients in the Imfinzi/FLOT arm and 43% of those in the placebo/FLOT arm were still receiving treatment.

“When it comes to exposure, we actually did quite well with FLOT in this global study, suggesting that FLOT is feasible as a global treatment,” she noted. “Ninety-seven percent of patients received all preoperative FLOT and 63% of patients received adjuvant FLOT in completion.”

She added that they also broke it down further by PD-L1 expression and found that the delivery of FLOT was “feasible and quite good.” When looking at the pathologic staging of patients who underwent surgery, 52% and 36% of patients in the respective Imfinzi and placebo arms had node-negative status. She added that there was also a higher percentage of patients who achieved a disappearance of cancer with Imfinzi/FLOT versus placebo/FLOT, at 23% and 11%, respectively, “as suggested by the higher pCR rate.”

Moreover, a higher percentage of patients in Asia had an ECOG performance status of 0, gastric cancer, lymph node positivity, and metastatic disease. “Despite this imbalance in the patient characteristics between Asia vs non-Asia, there was a balance between each arm — it’s just regional differences,” she noted, adding that the pCRs achieved in the Asia and non-Asia groups were comparable.

“Across Europe, North America, and South America, there was a nice and steady improvement in (pCR) with the addition of (Imfinzi) across the regions, which is very reassuring to see,” Janjigian said.

In countries with at least 20 randomized patients, the same improvement trend in pCR with the addition of Imfinzi to FLOT was observed.

“We’re all eagerly awaiting the EFS and PFS (data) in these patients,” Janjigian concluded.

Imfinzi plus chemotherapy, when given before surgery, improved pathologic complete response rates, regardless of region, in certain patients with gastric or gastroesophageal junction cancers. 

Imfinzi, Chemo Improves Outcomes in GI Cancers, Regardless of Region

The addition of Tecentriq (atezolizumab) to neoadjuvant Herceptin (trastuzumab) plus Perjeta (pertuzumab) and chemotherapy was shown to improve the number of pathologic complete responses (pCR) compared to Perjeta plus chemotherapy in patients with HER2-positive operable breast cancer.

However, there was no statistically significant difference between the two treatment groups, meaning that the researchers could not definitively say that one treatment was better than the other when it came to pCR.

The pCR achieved with Perjeta plus carboplatin and paclitaxel (223 patients) was 52.0% vs 57.8% with Tecentriq plus Herceptin, Perjeta and chemotherapy (HPCT) with or without anthracyclines (438 patients). However, there was an approximate 9.1% likelihood that the difference between these two groups happened by chance, rather than the difference in treatments. pCR was defined as the absence of invasive cells in the breast and lymph nodes.

The pCR achieved in those who received Adriamycin (doxorubicin) and Cytoxan (cyclophosphamide) and Tecentriq followed by HPCT (218 patients) was significantly higher than that achieved with HPCT alone, at 61.9% vs 52.0%, respectively. No significant difference in pCR was observed in those who received Tecentriq plus HPCT without anthracyclines (220 patients) compared with those given HPCT alone, at 53.6% vs 52.0%, respectively, a difference which, once again, was not statistically significant.

“An exploratory analysis shows a statistically significant higher rate of pCR with (Tecentriq) added to (doxorubicin and cyclophosphamide) followed by HPTC compared with control HPCT, suggesting either a direct anthracycline effect or a mechanistic enhancement of (doxorubicin and cyclophosphamide) with Tecentriq,” Dr. Luca Gianni, study investigator and chair of the International Breast Cancer Research Committee at Fondazione Michelangelo in Milano, Italy, stated in a presentation of the data.

For patients with high-risk HER2-positive breast cancer, neoadjuvant dual targeting of HER2 with HP and chemotherapy serves as the standard of care. Prior findings have indicated that the immune system plays a central role in prognosis and response achieved with HER2-directed approaches, and this has led to the exploration of pairing immune checkpoint inhibitors with HER2-directed antibodies, according to Gianni.

The open-label phase 3 APTneo trial enrolled 661 patients with operable or locally advanced HER2-positive breast cancer who had not previously been exposed to chemotherapy. These patients were randomly assigned to one of three arms:

Those in arm A received Herceptin at an initial dose of 8 mg/kg and 6 mg/kg thereafter plus Perjeta at an initial dose of 840 mg and 420 mg thereafter plus carboplatin on days 1 and 8 every 21 days and paclitaxel at 90 mg/m2 on days 1 and 8 every 21 days for 6 cycles. No later than four weeks after the last dose of neoadjuvant treatment, patients underwent definite surgery.They went on to receive adjuvant Perjeta for another 12 cycles.

Those in arm B1 received Adriamycin at 60 mg/m2 every 21 days plus cyclophosphamide at 600 mg/m2 every 21 days for three cycles followed by HPCT for three cycles plus Tecentriq at 1200 mg every three weeks. They went on to receive surgery and adjuvant HP and Tecentriq for an additional 12 cycles.

Those in arm B2 were given HPCT plus Tecentriq for six cycles followed by surgery and adjuvant Perjeta and Tecentriq for an additional 12 cycles.

The primary end point of the trial is focused on comparing event-free survival (EFS; the measure of time from treatment that a group of people in a clinical trial has not had cancer come back/worsen) between arm A and arm B at five years after the last patient is randomized.pCR serves as an important secondary end point, Gianni noted. Investigators will also examine the tolerability of the different regimens and conduct molecular analyses to identify predictive markers of benefit and/or resistance to the approaches.

The main patient characteristics at the time of randomization in the intent-to-treat population were “very well balanced,” Gianni said. The median patient age in arm A was 50 years in arms B1 and B2, the median patient ages were 50 years and 49 years, respectively. He highlighted that greater than 44% of patients across arms A, B1, and B2 had locally advanced disease and approximately 30% had PD-L1 positivity. Moreover, 39.0%, 34.9% and 30.9% of patients, respectively, had estrogen receptor negativity.

“In a multivariate analysis, treatment with anthracyclines, PD-L1–positive expression, negative expression of the estrogen receptor, and the presence of 30% (or higher) stromal tumor-infiltrating lymphocytes (sTILs) were all associated with higher probability of pCR,” Gianni reported.

“Tecentriq did not cause major tolerability issues,” Gianni said.

Any-grade treatment-related side effects occurring in at least 15% of patients across arms A, B1 and B2, respectively, included anemia (19.6%; 19.9%; 24.5%), weakness/lack of energy (26.5%; 38.9%; 29.6%), constipation (6.8%; 16.2%; 8.8%), diarrhea (64.8%; 52.8%; 64.8%), fatigue (21.5%; 22.2%; 19.4%), mucosal inflammation (13.7%; 17.1%; 20.4%), nausea (42.9%; 53.7%; 44.9%), neutropenia (23.7%; 25.9%; 24.5%), decreased neutrophil count (18.3%; 15.7%; 18.5%), rash (12.3%; 5.1%; 15.3%) and vomiting (16.0%; 22.7%; 18.5%).

The most common grade 3 or higher treatment-related side effects reported in arm A were decreased neutrophil count (12.3%), neutropenia (11.9%), diarrhea (3.2%), anemia (1.4%), weakness/lack of energy (0.9%), fatigue (0.5%) and mucosal inflammation (0.5%). In arm B1, the most common grade 3 or higher treatment-related side effects comprised neutropenia (16.2%), decreased neutrophil count (10.6%), diarrhea (6.9%), anemia (3.7%), asthenia (3.7%), vomiting (0.9%), fatigue (0.9%), mucosal inflammation (0.5%), and nausea (0.5%). In arm B2, the most common grade 3 or higher treatment-related side effects was neutropenia (14.8%), followed by decreased neutrophil count (10.6%), diarrhea (6.4%), anemia (2.3%), asthenia (2.3%), vomiting (1.9%), mucosal inflammation (0.9%), rash (0.6%) and fatigue (0.5%).

There was one episode of sudden death during neoadjuvant treatment in the control arm.

“We also looked very carefully at immune-mediated side effects and infusion reactions given the characteristics of the drugs we’re using in the trial,” Gianni said. “Mostly, the treatment-related side effects associated with Tecentriq were hyperthyroidism and hypothyroidism. But overall, if you look at grade 3 (or higher) immune-mediated side effects, they were not very frequent, and all of them could be effectively treated and controlled clinically.”

The study will continue follow-up until analysis of the primary end point of EFS, he concluded.

A recent phase 3 APTneo Michelangelo trial added Tecentriq to neoadjuvant Herceptin plus Perjeta and chemotherapy which did not lead to a statistically significant improvement in pathologic complete response in patients with HER2-positive operable breast cancer.

Kristi Rosa

Adding Tecentriq to Chemo Did Not Boost TNBC Survival

Keytruda Plus Cabometyx Produces Responses in Cisplatin-Ineligible Bladder Cancer

Imfinzi, Chemo Improves Outcomes in GI Cancers, Regardless of Region

Tecentriq Plus Perjeta, Herceptin, Chemo Does Not Improve pCR in HER2+ Breast Cancer

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