IMFINZI (durvalumab) injection
Astrazeneca
EXPANDED INDICATION: Treatment of patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy
ADDRESSING UNMET NEED:
- Lung cancer is the leading cause of cancer death in the United States, with an estimated 222,500 new diagnoses and 155,870 deaths in 2017
- First treatment approved for stage III unresectable NSCLC
- An approved therapy to keep the cancer from progressing for a longer time after chemoradiation
EFFICACY:
- Randomized trial, n=713 patients whose cancer had not progressed after completing chemotherapy and radiation, IMFINZI vs. placebo
- Major efficacy outcome: Progression-free survival (PFS) assessed by a BICR RECIST 1.1 and overall survival (OS)
- PFS: 45% vs. 66%, p<0.0001
SAFETY:
- Common side effects: Cough, fatigue, pneumonitis/radiation pneumonitis, upper respiratory tract infections, dyspnea, rash
- Serious risks: Immune-mediated side effects, such as pneumonitis, hepatitis, colitis, endocrinopathies, nephritis
REGULATORY PATHWAY: sBLA
- Priority Review, Breakthrough status
- Postmarketing commitments: Overall Survival data, efficacy outcomes in subgroups defined by ADA binding and neutralizing status vs. control
- Granted accelerated approval in 2017 for the treatment of locally advanced or metastatic bladder cancer
REIMBURSEMENT:
- HCPCS Code: C9492, special coverage
- CPT codes for infusion administration and home infusion
VERZENIO (abemaciclib) tablets
Eli Lilly
EXPANDED INDICATION: In combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
ADDRESSING UNMET NEED: Initial therapy for HR-positive, HER2-negative metastatic breast cancer
EFFICACY:
- Randomized (2:1), double-blinded, placebo-controlled, multicenter clinical trial in postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, n=493, VERZENIO vs placebo on top of physician’s choice of letrozole or anastrozole
- Primary endpoint: Progression-free survival (PFS) (RECIST 1.1): 28.2 mo. vs. 4.8 mo., p<0.0001
SAFETY:
- Most common adverse reactions: Diarrhea, neutropenia, fatigue, infections, nausea, abdominal pain, anemia, vomiting, alopecia, decreased appetite, leukopenia
REGULATORY PATHWAY: NDA
- Priority Review
- Postmarketing commitments: Overall Survival data
- Initial approval in 2017
REIMBURSEMENT
- No Medicare coverage
- Obtained through specialty pharmacies
Image credit: AstraZeneca, Eli Lilly