Liver, Gastric Cancer Priority Reviews Highlight Week in Cancer News


Top news of the week in oncology and cancer drug development.

FDA Approves Ceritinib for Frontline ALK+ NSCLC

The FDA has approved ceritinib (Zykadia) for the treatment of patients with ALK-positive, metastatic non—small cell lung cancer (NSCLC). Patients’ ALK-positive status must be determined by an FDA-approved test. The approval is based on findings from the phase III ASCEND-4 trial, in which ceritinib reduced the risk of disease progression or death by 45% compared with standard chemotherapy.

The median progression-free survival (PFS) benefit favoring ceritinib was 8.5 months (HR, 0.55; 95% CI, 0.42-0.73; P <.0001). The FDA granted ceritinib an accelerated approval in April 2014 for the treatment of patients with ALK-positive advanced NSCLC previously treated with crizotinib (Xalkori). The FDA has converted that second-line approval into a full approval.

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FDA Approves Pembrolizumab for Microsatellite Instability-High and Mismatch Repair Deficient Cancers

The FDA has granted an accelerated approval to pembrolizumab (Keytruda) for the treatment of patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed after prior treatment and who have no satisfactory alternative treatment options, as well as for patients with MSI-H or dMMR colorectal cancer following progression on a fluoropyrimidine, oxaliplatin, and irinotecan.

This is the first FDA approval for a cancer drug based on a tumor’s biomarker without regard to the tumor’s original location. The approval was based on data from 149 patients with MSI-H or dMMR cancers enrolled across 5 single-arm clinical trials. Ninety patients had colorectal cancer (CRC) and the remaining 59 patients had 1 of 14 other tumor types. The objective response rate (ORR) with pembrolizumab was 39.6% (95% CI, 31.7-47.9), including 11 (7.4%) complete responses (CRs) and 48 (32.2%) partial responses (PRs). The ORR was 36% in patients with CRC and 46% in patients with other tumor types. The median duration of response was not yet reached (range, 1.6+ months to 22.7+ months). Among patients who responded to pembrolizumab, 78% had responses that lasted for at least 6 months.

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FDA Grants Adjuvant Sunitinib Priority Review in High-Risk RCC

The FDA has granted a priority review designation to sunitinib (Sutent) for use as an adjuvant therapy in patients with renal cell carcinoma who have received nephrectomy and are high risk for recurrence. The supplemental new drug application for sunitinib is based on findings from the phase III S-TRAC trial, in which, adjuvant sunitinib prolonged disease-free survival (DFS) by 1.2 years compared with placebo following nephrectomy for patients with high-risk clear cell RCC.

After a median follow-up duration of 5.4 years, the median DFS was 6.8 years in the sunitinib arm compared with 5.6 years with placebo (HR, 0.76; 95% CI, 0.59-0.98; P = .03). In higher risk patients, the median DFS was 6.2 versus 4.0 years for sunitinib and placebo, respectively (HR, 0.74; 95% CI, 0.55-0.99; P = .04). Grade 3/4 adverse events were experienced by 63.4% of patients in the sunitinib group compared with 21.7% in the placebo arm. The FDA is scheduled to make its final decision by January 2018.

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FDA Grants Priority Review to CPX-351 for AML

The FDA has accepted a new drug application (NDA) from Jazz Pharmaceuticals, granting priority review to the company’s novel CPX-351 injection (Vyxeos) for acute myeloid leukemia (AML). CPX-351 is an investigational nano-scale liposome co-formulation of cytarabine and daunorubicin at a synergistic 5:1 molar ratio. The NDA submission includes clinical data from 5 studies, including data from the pivotal phase III study comparing the formulation with cytarabine and daunorubicin (7+3) were presented at last year’s ASCO Annual Meeting.

Those phase III results showed that CPX-351 reduced the risk of death by 31% compared with 7+3 for older patients with high-risk, secondary AML. The formulation showed a median overall survival of 9.56 months (95% CI, 6.60-11.86) versus 5.95 months (95% CI, 4.99-7.75) with 7+3 (HR, 0.69; P = .005). At 12 months, 41.5% of patients enrolled in the CPX-351 arm were alive versus 27.6% in the 7+3 arm. At 24 months, 31.1% of patients enrolled in the CPX-351 arm of the study remained alive compared with 12.3% with 7+3.

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FDA Grants Priority Review to KTE-C19 for Non-Hodgkin Lymphoma

The FDA has granted a priority review to the CD19-directed chimeric antigen receptor (CAR) T-cell therapy axicabtagene ciloleucel for transplant-ineligible patients with relapsed or refractory non-Hodgkin lymphoma. The priority review was based on data from the phase II ZUMA-1 study, which was presented at the 2017 AACR Annual Meeting.

In the study, axicabtagene ciloleucel demonstrated an objective response rate of 82% and a complete response (CR) rate of 54%. After 8.7 months of follow-up, 39% of patients continued to have a CR. The FDA is scheduled to make its decision by November 29, 2017.

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FDA Grants Nivolumab Priority Review for Liver Cancer

The FDA has granted a priority review designation to nivolumab (Opdivo) for use as a treatment for patients with hepatocellular carcinoma following prior sorafenib (Nexavar). The FDA is scheduled to make it its final decision on or before September 24, 2017. The supplemental biologics license application for nivolumab is based on safety and efficacy findings from the phase I/II CheckMate-040 trial.

In the dose-escalation phase of the trial, the overall objective response rate (ORR) was 15% (95% CI, 6-28), including 3 complete responses (CRs) and 4 partial responses (PRs). Five of the 7 responses occurred with 3 months of initiating nivolumab. In the expansion phase of the trial, the ORR was 20% (42/214; 95% CI, 15-26), including 3 CRs and 39 PRs. Twenty-nine (69%) of the 42 responses occurred before 3 months.

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FDA Grants Pembrolizumab Priority Review for Advanced Gastric Cancer

The FDA has granted a priority review to a supplemental Biologics License Application for pembrolizumab (Keytruda) for the treatment of patients who have undergone at least 2 courses of chemotherapy for recurrent or advanced gastric or gastroesophageal junction adenocarcinoma. The agency is expected to announce a decision by September 22, 2017. The application is based on data from cohort 1 of the phase II KEYNOTE-059 trial, a multicohort, international study. In KEYNOTE-059, adult patients (n = 259) with advanced gastric or gastroesophageal junction cancer who had progressed on at least 2 prior lines of chemotherapy were assigned to 200 mg of pembrolizumab every 3 weeks for up to 2 years, or until progression or unacceptable toxicity.

Just over half of patients (51.7%) received treatment as third-line therapy and 48.3% received pembrolizumab in the fourth line. At a median follow-up was 5.4 months, objective response rate was 11.2% (95% CI, 7.6-15.7). More specifically, 1.9% (95% CI, 0.6-4.4) of patients had a complete response, 9.3% (95% CI, 6.0-13.5) had a partial response, 17% (95% CI, 12.6-22.1), had stable disease, and 55.6% (95% CI, 49.3-61.7) experienced disease progression. Median duration of response was 8.1 months.

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FDA Panel Supports Neratinib Approval for HER2+ Breast Cancer

The FDA’s Oncologic Drugs Advisory Committee voted 12-4 recommending approval of neratinib (Nerlynx) for the extended adjuvant treatment of patients with early stage, HER2-positive breast cancer following postoperative trastuzumab (Herceptin). ODAC based its recommendation on data from the phase III ExteNET trial and the phase II CONTROL trial. In the primary analysis of the ExteNET trial, the invasive disease-free survival (iDFS) rate at 2 years was 94.2% with neratinib versus 91.9% with placebo (stratified hazard ratio [HR], 0.66; 95% CI, 0.49-0.90; stratified log-rank P-value [two-sided] =.008).

The results indicated that the benefit may vary based on hormone receptor (HR) status. An exploratory subgroup analysis indicated that neratinib lowered the risk of recurrence by 51% (HR, 0.49; 95% CI, 0.31-0.75) in HR-positive patients, compared with 7% in HR-negative patients (HR, 0.93; 95% CI, 0.60-1.43). Diarrhea was the primary safety concern with neratinib considered by the panel, as 95% of patients in the ExteNET trial who received the tyrosine kinase inhibitor experienced the adverse event, including grade 3 diarrhea in 40% of patients. Diarrhea led to study discontinuation for 16.8% of patients. However, results from the ongoing phase II CONTROL trial suggest that antidiarrheal prophylaxis can control the occurrence and severity of diarrhea among patients receiving neratinib. The FDA will now make its final decision on neratinib. The agency is not required to follow the ODAC recommendation.

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ODAC Recommends Approval of Epoetin Alfa Biosimilar

The FDA’s Oncologic Drugs Committee voted 14-1 to recommend approving a biologics license application for epoetin hospira (Retacrit), an epoetin alfa (Epogen/Procrit) biosimilar manufactured by Hospira. The BLA will now go to the FDA for consideration. The agency denied Hospira’s application for an abbreviated Biologics License Application in 2015. ODAC staff recommended approval, concluding that epoetin hospira is “highly similar to US-licensed Epogen/Procrit.”

In evaluating the request from Hospira, a division of Pfizer, committee members kept coming back to the same conclusion: “The totality of the analytical similarity data supports the conclusion that epoetin hospira is highly similar to US-licensed Epogen/Procrit, notwithstanding minor differences in clinically inactive components. The clinical data, including pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity data support a finding of no clinically relevant differences.”

Hospira is seeking approval for 4 indications: to treat anemia due to chronic kidney disease, including patients on dialysis and not on dialysis to decrease the need for red blood cell transfusion; to treat anemia in HIV-infected patients being treated with zidovudine; to treat chronic renal failure, specifically anemia caused by concomitant myelosuppressive chemotherapy in patients with non-myeloid malignancy; and to reduce the need for allogeneic red blood cell transfusions in patients with perioperative hemoglobin from >10 g/dL to ≤13 g/dL who are at high risk for perioperative blood loss from elective noncardiac, nonvascular surgery.

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Ramucirumab Improves PFS in Phase III Urothelial Carcinoma Trial

Adding ramucirumab (Cyramza) to docetaxel led to a statistically significant improvement in progression-free survival versus docetaxel alone in previously treated patients with locally advanced or unresectable or metastatic urothelial carcinoma, according to results from the phase III RANGE trial. Eli Lilly and Company, the manufacturer of the VEGFR-2 antagonist, announced the results in a press release.

The company said these are the first phase III results to demonstrate superior PFS over chemotherapy in a post-platinum setting in urothelial cancer for any therapy. These are also the first phase III results to provide evidence that an antiangiogenic agent can extend PFS in urothelial cancer. A company spokesperson said the study data will be released at an as-yet-undetermined scientific meeting. Final OS results should be ready for publication next year.

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