NSCLC Survival Not Improved By Adjuvant Bevacizumab

“When bevacizumab (Avastin) was added to adjuvant chemotherapy, overall survival (OS) did not improve in patients with surgically resected early-stage non-small cell lung cancer (NSCLC), according to findings of the phase III E1505 trial presented during a press conference at the 2015 World Conference on Lung Cancer.

“The phase III trial randomized 1501 patients with NSCLC in a 1:1 ratio to chemotherapy with bevacizumab (n = 752) or without (n = 749). Data revealed that OS did not differ between the two arms (hazard ratio [HR], 0.99; 95% CI, 0.81-1.21; P = .93); median OS was more than 72 months in both cohorts. Similar data was reported with disease-free survival, a secondary endpoint, between the two arms (HR, 0.98; 95% CI, 0.84-1.14; P = .75).”

Cetuximab Finds Niche in Non-Small Cell Lung Cancer

“Adding the EGFR inhibitor cetuximab (Erbitux) to chemotherapy failed to improve survival in patients with advanced non-small cell lung cancer, a multicenter randomized trial showed.

“The primary analysis showed a median overall survival of 10.9 months compared with 9.4 months, a difference that did not achieve statistical significance (HR 0.94, 95% CI 0.84-1.06). The trial also failed to demonstrate improvement in progression-free survival for patients with EGFR-positive disease, the co-primary endpoint.

“However, cetuximab led to a 25% reduction in hazard ratio among patients who had EGFR-positive tumors by fluorescence in situ hybridization (FISH) and were not candidates for bevacizumab (Avastin), a prespecified secondary endpoint. An exploratory analysis analysis showed that patients with EGFR-positive, squamous-cell tumors lived almost twice as long with cetuximab as with chemotherapy alone (11.8 vs 6.4 months, P=0.006), as reported here at the World Conference on Lung Cancer.”

Biothera Presents Additional Data at ASCO on Durability and Characteristics of Response with Imprime PGG in Non-Small Cell Lung Cancer Study

“Biothera’s investigational cancer immunotherapy Imprime PGG in combination with standard platinum-based doublet chemotherapy and the monoclonal antibody bevacizumab achieved rapid and lasting responses in patients with non-squamous non-small cell lung cancer (NSCLC). Tumor reduction was observed regardless of tumor burden (up to > 30 cm) or location of lesions at baseline (including lung, lymph nodes, adrenals, liver). These findings were presented yesterday during a poster session at the annual meeting of the American Society of Clinical Oncology (abstract #3070).

“During Biothera’s randomized clinical study in non-squamous NSCLC, patients received four to six cycles of Imprime PGG in combination with bevacizumab and carboplatin/ paclitaxel chemotherapy. These treatment cycles were followed by a maintenance therapy phase consisting of bevacizumab with or without Imprime PGG.

“Overall, the objective response rate was 60.4% with Imprime PGG versus 43.5% in the control group. Time to response was short (12 weeks vs. > 16 weeks), and responses were durable with Imprime PGG (10.3 months vs. 5.6 months). In the maintenance phase, further meaningful tumor reductions were observed in 20% of patients in the Imprime PGG group, but none in the control group. These findings were associated with numerical increases in overall survival: at the 1-year mark (following treatment start) 62.8% of patients on Imprime PGG remained alive, compared with 42.7% of patients in the control group.”

Biothera Immunotherapy Combination Results in Tumor Reduction During Maintenance Phase of Non-Small Cell Lung Cancer Study

“The combination of the investigational cancer immunotherapy Imprime PGG and the monoclonal antibody bevacizumab achieved additional meaningful reductions in tumor burden during the maintenance phase of Biothera’s recent phase 2 clinical trial in non-small cell lung cancer (NSCLC). The new data will be released today at the European Lung Cancer Conference.

“Biothera conducted a randomized Phase 2 clinical study in non-squamous NSCLC in which Imprime PGG was administered in combination with bevacizumab and platinum-based doublet chemotherapy. After four to six cycles of treatment, patients received maintenance therapy of bevacizumab with or without Imprime PGG. Further meaningful reductions in tumor burden (>10mm) were observed in 6 (20%) of patients in the Imprime PGG group, but not in the control group.

“ ‘Patients receiving the combination of Imprime PGG and bevacizumab experienced further reduction in their tumor burden than with bevacizumab therapy alone,’ said Ada Braun, M.D., Ph.D., Biothera Chief Medical Officer. ‘These results highlight the efficacy of Imprime PGG and show the potential for continued tumor regressions on chemotherapy-free maintenance therapy for some patients.’ ”

Genentech Distribution Shift for Cancer Meds Delays Patient Care: Survey

“A new survey of hospitals and academic medical centers finds that a recent move by Genentech to switch distribution of three widely used cancer treatments – Avastin, Rituxan and Herceptin – is resulting in higher costs, reduced access to the medications and delays in treating patients. And the institutions are hoping the results will prompt the drug maker, which says it’s unaware of such problems, to revert to its earlier distribution program.

“Here’s the background: Last fall, Genentech began using just a few distributors that specialize in handling such medicines. Until then, the Roche unit used dozens of wholesalers, although the specialty distributors are actually divisions of some of those same wholesalers. Genentech says the change was made to save money, but also make distribution more efficient and prevent the possibility of shortages.

“However, most of the institutions – 93% – say they had not experienced shortages, and the move has disrupted not only their finances, but patient care. The survey also found that 81% say the switch will have a moderate to significant impact on their expenses. Meanwhile, 63% say deliveries have been unreliable and 88% reported a delay in patient treatment because one of the drugs was unavailable.

“The institutions say they are forced to increase inventories to hedge against any supply disruptions that may occur because shipping can take longer, depending upon the location of the distributor. Some institutions say they cannot afford to keep large amounts of drug on hand, which can result in delays in treating new patients or unexpected events. And previous discounts may no longer be available.”

Adding Bevacizumab to Endocrine Therapy No Help in Advanced Breast Cancer

“The addition of bevacizumab did not prolong progression-free survival (PFS) or overall survival in postmenopausal women with HER2-negative, hormone receptor–positive advanced breast cancer treated with first-line endocrine therapy.

“The results of the Letrozole/Fulvestrant and Avastin (LEA) study were published in the Journal of Clinical Oncology.

“The median PFS was 14.4 months in the endocrine therapy arm and 19.3 months in the endocrine therapy plus bevacizumab arm (hazard ratio = 0.83; P = .126). The overall response rate was 22% and 41% in the control arm and the bevacizumab arm (P < .001). The duration of response was 13.3 months in the control arm compared with 17.6 months in the bevacizumab arm (P = .434). The time to treatment failure and overall survival were similar in both treatment arms.

“Study author Miguel Martín, MD, PhD, of Complutense University of Madrid told Cancer Network that there was a trend towards a better PFS in favor of the combination of bevacizumab and hormones. ‘Therefore, we cannot simply conclude that bevacizumab is ineffective in this setting.’ “

PET Scan Could Predict Response to Pre-Surgery Treatment with Chemo + Herceptin

The gist: A recent clinical trial found that positron emission tomography (PET) scans could be used to predict how well a patient will respond to neoadjuvant (pre-surgery) treatment with chemotherapy and trastuzumab (Herceptin). Doctors might recommend a change in treatment to a patient whose PET scans show that current treatment isn’t working. In the study, researchers treated women with early-stage, HER2-positive breast cancer. Based on PET scans, the researchers were able to predict which patients would still have signs of an invasive tumor after treatment. They also found that adding the drug bevacizumab (Avastin) to the treatment plan could improve responses for some of these patients.