Frontline Atezolizumab Benefit in NSCLC Sustained Across Biomarker-Driven Subgroups

Excerpt:

“Adding atezolizumab (Tecentriq) to chemotherapy and an angiogenesis inhibitor led to significant improvement in progression-free survival (PFS) for patients with untreated advanced nonsquamous non–small cell lung cancer (NSCLC), according to results from an ongoing trial presented at the 2018 AACR Annual Meeting.

“In the IMpower150 trial, patients who received the PD-L1 inhibitor along with bevacizumab (Avastin) and chemotherapy had a median PFS of 8.3 months compared with 6.8 months with bevacizumab and chemotherapy. The difference translated into a 38% reduction in the hazard for progression or death (HR, 0.62; 95% CI, 0.52-0.74; P <.0001).”

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Opdivo Plus Low-Dose Yervoy Combination Reduces the Risk of Progression or Death by 42% Versus Chemotherapy in First-Line Lung Cancer Patients with High Tumor Mutational Burden (TMB)

Excerpt:

Bristol-Myers Squibb Company (NYSE: BMY) today announced initial results from the pivotal Phase 3 study, CheckMate -227, evaluating the Opdivo (nivolumab) 3 mg/kg plus low-dose Yervoy (ipilimumab, 1 mg/kg) combination in first-line advanced non-small cell lung cancer (NSCLC) patients with high tumor mutational burden (TMB) ≥10 mutations/megabase (mut/Mb). In the study, the combination demonstrated a superior benefit for the co-primary endpoint of progression-free survival (PFS) versus chemotherapy (HR 0.58; 97.5% CI: 0.41 to 0.81; p=0.0002). The PFS benefit was observed regardless of PD-L1 expression levels and in both squamous and non-squamous tumor histology. Additionally, based on an early descriptive analysis, encouraging overall survival was observed with the combination versus chemotherapy in patients with high TMB ≥10 mut/Mb (HR 0.79; 95% CI: 0.56 to 1.10).”

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Merck’s KEYTRUDA® (Pembrolizumab) Plus Pemetrexed (ALIMTA®) and Platinum Chemotherapy Reduced the Risk of Death by Half Compared with Chemotherapy Alone as First-Line Treatment for Advanced Nonsquamous NSCLC in Phase 3 KEYNOTE-189 Study

Excerpt:

“Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced results from KEYNOTE-189, a pivotal Phase 3 trial evaluating KEYTRUDA ® , Merck’s anti-PD-1 therapy, in combination with pemetrexed (ALIMTA®) and cisplatin or carboplatin for the first-line treatment of metastatic nonsquamous non-small cell lung cancer (NSCLC). Findings showed that the KEYTRUDA-pemetrexed-platinum chemotherapy combination significantly improved overall survival (OS), reducing the risk of death by half compared with chemotherapy alone (HR=0.49 [95% CI, 0.38-0.64]; p<0.00001). In pre-specified exploratory analyses, an OS benefit was observed regardless of PD-L1 expression in the three PD-L1 categories that were evaluated, including: patients whose tumors were negative for PD-L1 (HR=0.59 [95% CI, 0.38-0.92]); patients whose tumors had PD-L1 tumor proportion scores (TPS) of 1-49 percent (HR=0.55 [95% CI, 0.34-0.90]); and patients who had a TPS of greater than or equal to 50 percent (HR=0.42 [95% CI, 0.26-0.68]). The addition of KEYTRUDA to pemetrexed plus platinum chemotherapy also achieved a significant improvement in progression-free survival (PFS), with a reduction in the risk of progression or death of nearly half for patients in the KEYTRUDA combination arm, compared with chemotherapy alone (HR=0.52 [95% CI, 0.43-0.64]; p<0.00001). A PFS improvement in the KEYTRUDA combination group was observed in patients whose tumors were negative for PD-L1 (HR=0.75 [95% CI, 0.53-1.05]); patients with a TPS of 1-49 percent (HR=0.55 [95% CI, 0.37-0.81]); and patients with a TPS greater than or equal to 50 percent (HR=0.36 [95% CI, 0.25-0.52]). These results are being presented today in a plenary session at the American Association for Cancer Research (AACR) Annual Meeting 2018 (Abstract #CT075), with simultaneous publication in The New England Journal of Medicine.”

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Neoadjuvant Nivolumab was Safe, Yielded Pathologic Responses in Patients With Resectable Lung Cancer

Excerpt:

“The anti-PD1 immunotherapy nivolumab (Opdivo) given prior to surgical resection of stage 1-3 non-small cell lung cancer (NSCLC) was safe and resulted in major pathological responses in 45 percent of the patients, according to data from a clinical trial presented at the AACR Annual Meeting 2018, April 14-18.

“A major pathologic response is defined as 10 percent or fewer viable cancer cells detectable in the resected tumor following neoadjuvant treatment.”

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AstraZeneca Wins U.S. Approval for 1st-Line Use of Lung Cancer Drug

Excerpt:

“U.S. regulators have expanded use of AstraZeneca’s lung cancer drug Tagrisso to include initial treatment of patients with a specific genetic mutation, the company said on Wednesday.

“The latest Food and Drug Administration approval includes patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test.

“Tagrisso, also known as osimertinib, was already approved for use in patients whose lung cancer worsened after treatment with other EGFR therapies and who have developed a secondary mutation.”

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Keytruda (Pembrolizumab) Monotherapy Met Primary Endpoint in Phase 3 KEYNOTE-042 Study, Significantly Improving OS as First-Line Therapy in Locally Advanced or Metastatic NSCLC Patients Expressing PD-L1 in at Least 1 Percent of Tumor Cells

Excerpt:

“Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the pivotal Phase 3 KEYNOTE-042 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC, including nonsquamous or squamous histologies) met its primary endpoint of overall survival (OS). An interim analysis conducted by the independent Data Monitoring Committee (DMC) demonstrated that treatment with KEYTRUDA resulted in significantly longer OS than platinum-based chemotherapy (carboplatin plus paclitaxel or carboplatin plus pemetrexed) in patients with a PD-L1 tumor proportion score (TPS) of ≥1 percent. As part of a pre-specified analysis plan, OS was sequentially tested and was significantly improved in patients with a TPS of ≥50 percent, with a TPS of ≥20 percent and then in the entire study population with a TPS of ≥1 percent. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported monotherapy studies involving patients with advanced NSCLC.”

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New Immunotherapy for Lung Cancer Shows Promise of Success

Excerpt:

“In a groundbreaking development, results from a recent clinical trial to treat lung cancer show that a novel immunotherapy combination is surprisingly effective at controlling the disease’s progression. The study, published April 4 in the journal The Lancet Oncology, focused on non-small cell lung cancer, which is the most common form of lung cancer.”

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Phase III IMpower150 Study Showed Roche’s TECENTRIQ (Atezolizumab) and Avastin (Bevacizumab) Plus Carboplatin and Paclitaxel Helped People with Advanced Lung Cancer Live Longer Compared to Avastin Plus Carboplatin and Paclitaxel

Excerpt:

“Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMpower150 study met its co-primary endpoint of overall survival (OS) at this interim analysis and showed that initial (first-line) treatment with the combination of TECENTRIQ® (atezolizumab) and Avastin® (bevacizumab) plus carboplatin and paclitaxel (chemotherapy) helped people with advanced non-squamous non-small cell lung cancer (NSCLC) live significantly longer compared with Avastin plus carboplatin and paclitaxel. A survival benefit was observed across key subgroups, including those with varying levels of PD-L1 expression. Safety for the TECENTRIQ and Avastin plus carboplatin and paclitaxel combination appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combinations. These data will be presented at an upcoming oncology congress.”

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Tecentriq Combo Success Boosts Roche in Lung Cancer

Excerpt:

“A combination of Roche AG’s immunotherapy Tecentriq with two older cancer drugs bested chemotherapy in extending progression-free survival (PFS) among previously untreated patients with squamous non-small cell lung cancer (NSCLC), the Swiss pharma announced March 20.

“Results from the Phase 3 study, known as IMpower 131, could position Tecentriq as the first checkpoint inhibitor to market for first-line treatment of squamous NSCLC, a subset that accounts for 25% to 30%of all NSCLC cases.

“Roche only disclosed topline results for the combination regimen’s effect on PFS. At this point, no benefit in overall survival (OS) between the treatment and control groups was reported, but the study will continue to allow for further observation.”

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