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FEBRUARY 2019    A Monthly Review of Articles of Interest for the Clinical Community

..This Month's Clinical Focus:  LUNG CANCER..

 

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 Expansion of First-Line Treatment of Metastatic Nonsquamous Non-Small Cell Lung Cancer 

New FDA approval based on Phase 3 KEYNOTE-189 results

In the KEYNOTE-189 study, safety was evaluated in 405 patients who received ALIMTA in combination with pembrolizumab and platinum chemotherapy and 202 patients who received placebo, ALIMTA and platinum chemotherapy. ALIMTA was discontinued for adverse reactions in 23 percent of patients in the ALIMTA-pembrolizumab-platinum chemotherapy arm.
 

Virus Cells in Lungs by kjpargeter FREEPIK Free Lic CC0

 

"KEYNOTE-189 demonstrated an exceptional effect of the ALIMTA-pembrolizumab-platinum chemotherapy combination in the first-line setting, offering significantly improved survival in patients with metastatic nonsquamous non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations," said Anne White, president, Lilly Oncology. Continued approval was contingent upon verification and description of clinical benefit, which has now been demonstrated in the KEYNOTE-189 trial.
 

Conducted by Merck, (in collaboration with Lilly), the KEYNOTE-189 trial (ClinicalTrials.gov, NCT02578680), a randomized, double-blind, placebo-controlled, Phase 3 study, evaluated ALIMTA in combination with pembrolizumab and cisplatin or carboplatin compared with ALIMTA in combination with placebo and cisplatin or carboplatin, in 616 untreated patients with metastatic nonsquamous NSCLC, regardless of PD-L1 expression. Patients had no sensitizing EGFR or ALK genomic tumor aberrations, and had not previously received systemic therapy for advanced disease.
 

This was a treat-to-progression protocol, with both ALIMTA and pembrolizumab being used until progression or unacceptable toxicity (or 35 cycles for pembrolizumab). Patients were randomized 2:1 to one of two treatment groups, as follows:

  • ALIMTA (500 mg/m2) (with vitamin supplementation) plus pembrolizumab (200 mg fixed dose every three weeks) plus cisplatin (75 mg/m2) or carboplatin AUC 5 mg/mL/min on day one every three weeks (Q3W) for four cycles, followed by ALIMTA (500 mg/m2) plus pembrolizumab 200 mg Q3W; or
  • ALIMTA (500 mg/m2) (with vitamin supplementation) plus
    saline placebo plus cisplatin (75 mg/m2) or carboplatin AUC 5 mg/mL/min on day one every three weeks (Q3W) for four cycles, followed by ALIMTA (500 mg/m2) plus placebo Q3W.

Patients on the control arm who experienced disease progression, verified by central independent review, were permitted to undergo treatment assignment unblinding and crossover to receive open-label pembrolizumab.
 

SOURCE: Used by Permission of PRNewswire
 


Phase 3 Trial of Rova-T as Second-Line Therapy for Advanced Small-Cell Lung Cancer Halted (TAHOE)

 

Independent Data Monitoring Committee responsible for ongoing review of study data recommended enrollment be stopped 

 

The decision was made to stop enrollment for the TAHOE trial, a Phase 3 study evaluating Rovalpituzumab Tesirine (Rova-T) as a second-line therapy for advanced small-cell lung cancer (SCLC). An Independent Data Monitoring Committee (IDMC) recommended stopping enrollment in TAHOE due to shorter overall survival in the Rova-T arm compared with the topotecan control arm. For patients currently on treatment with Rova-T in TAHOE, the IDMC recommended that investigators and patients make individual decisions as to whether or not to continue treatment based on patient level response. The recommendation from the IDMC to halt enrollment applies only to the TAHOE study and does not impact other Rova-T clinical studies.
 

Smokers Lungs by macrovector FREEPIK Free Lic CC0


The TAHOE trial is a randomized, open-label, two-arm, Phase 3 trial assessing the efficacy, safety and tolerability of Rova-T versus topotecan in participants with advanced or metastatic small-cell lung cancer (SCLC) with high levels of delta-like protein 3 (DLL3) and who have first disease progression during or following front-line platinum-based chemotherapy.
 

Rovalpituzumab Tesirine (Rova-T) is an investigational antibody-drug conjugate targeting the cancer-stem cell-associated delta-like protein 3 (DLL3) [See: Saunders L. R. et al. A DLL3-targeted antibody-drug conjugate eradicates high-grade pulmonary neuroendocrine tumor-initiating cells in vivo. Sci. Transl. Med. 2015;7(302): 1-13.], which is expressed in more than 80 percent of small-cell lung cancer (SCLC) patient tumors, where it is prevalent on tumor cells, including cancer stem cells, but not present in healthy tissue.  Rova-T combines a targeted antibody that delivers a cytotoxic agent directly to the DLL3-expressing cancer cells while minimizing toxicity to healthy cells. It is under investigation as a third-line treatment in SCLC. The expression of DLL3 suggests Rova-T may be useful across multiple tumor types, including metastatic melanoma, glioblastoma multiforme and some prostate, pancreatic and colorectal cancers. [See Study of Rovalpituzumab Tesirine (SC16LD6.5) for Third-line and Later Treatment of Subjects With Relapsed or Refractory Delta-Like Protein 3-Expressing Small Cell Lung Cancer in the TRINITY Trial].
 

As an investigational compound its efficacy and safety have not been established by the FDA or any other health authority. "Patients are our first priority and we are deeply grateful to the patients and physicians who participated in this trial," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "We remain committed to discovering and developing transformative therapies for people living with cancer."

 

SOURCE: Used by Permission of PRNewswire


Image credits: Lung Cells courtesy of kjpargeter; Red-Black Lung courtesy of macrovector; both via FreePIK.com Free Lic CC0;

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