Lung cancer is one of the most prevalent cancers in the world in both men and women. Statistics indicate that lung cancer is one of the leading causes of cancer related deaths in the United States. There are mainly two types of lung cancer - non-small cell lung cancer (NSCLC) and small cell lung cancer. Among these, NSCLC is more common and accounts for approximately 80-% of all the cases.
Non-small cell lung cancer comprises non-squamous and squamous-cell lung cancer. The squamous form mostly grows near the center of the lung and accounts for approximately 25-30% of all NSCLC cases.
Given the worldwide prevalence of NSCLC and the unmet need for novel treatments, a number of pharma/biotech companies have invested a significant amount of their R&D spend in making drugs for this indication. In particular, the first-line treatment of NSCLC is one of the major areas of interest and there has been a lot of activity of late.
Roche’s (RHHBY - Free Report) Avastin is currently approved in combination with any platinum-based chemotherapy in Europe and with paclitaxel/carboplatin in the United States in first-line non-squamous NSCLC. Of late, the space has witnessed the introduction of immunotherapies.
Let’s take a look at some of the companies that have immunotherapy drugs/candidates for NSCLC:
Leading the race in this space is Merck & Co’s (MRK - Free Report) anti-PD-1 therapy, Keytruda. Last month, the FDA approved an expanded label for Keytruda, in combination with Alimta and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations, based on results of the KEYNOTE-189 trial. The results from the trial showed that the combination demonstrated a statistically significant and clinically meaningful improvement in overall survival.
We note that Keytruda in combination with Alimta and carboplatin obtained FDA approval for the same in 2017 under the agency’s accelerated approval process. Continued approval of the same was contingent upon verification and description of clinical benefit. The positive readouts from the KEYNOTE-189 confirmatory study enabled the company to get the accelerated approval converted to a continued approval for the combo therapy, further reinforcing its position in the lung cancer market.
The European Commission also recently approved the combination for the first-line treatment of metastatic nonsquamous NSCLC in adults whose tumors have no EGFR or ALK positive mutations.
Merck’s shares have outperformed the industry in the year so far, gaining 22.7% compared with 5% increase for the industry.
Merck currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Swiss pharma giant Roche is one of the leading companies with its immuno-oncology drug Tecentriq being evaluated for NSCLC. While Tecentriq is already approved in the European Union and the United States for the treatment of patients suffering from previously treated metastatic NSCLC, the combination of Tecentriq and Avastin is being evaluated for the first-line treatment of advanced NSCLC.
Earlier in the month, Roche was notified by the FDA that the review period for the supplemental Biologics License Application (sBLA) for Tecentriq in combination with Avastin (bevacizumab), carboplatin and paclitaxel for the initial treatment of NSCLC has been extended by three months. The FDA needs extra time to review additional information requested in support of the sBLA and is expected to decide on approval by Dec 5. While the delay of three months was disappointing, a potential approval will expand the patient population for the combination.
Tecentriq in combination with Avastin was granted priority review by the FDA for the initial treatment of people with metastatic non-squamous NSCLC based on results from the phase III study, IMpower150 in May.
Roche currently carries a Zacks Rank #1. Year to date, shares of Roche have declined 3.5%.
Bristol-Myers Squibb (BMY - Free Report) is also evaluating its immuno-oncology drug Opdivo for the first-line treatment of NSCLC. In June, the FDA accepted the company’s sBLA for Opdivo in combination with low-dose Yervoy for the treatment of first-line advanced NSCLC in patients with tumor mutational burden (TMB) ≥10 mutations per megabase (mut/Mb). The submission was based on positive results from Part 1 of the ongoing phase III study, CheckMate -227.
The FDA has set a target action date of Feb 20, 2019. We note that Opdivo is already approved for the treatment of patients with metastatic NSCLC with progression on or after platinum-based chemotherapy.
Bristol-Myers currently sports a Zacks Rank #1. Bristol-Myers’ shares have declined 1.2% year to date.
Another player in this space is AstraZeneca’s (AZN - Free Report) immunotherapy drug Imfinzi. In February, the FDA approved Imfinzi for the treatment of patients with unresectable stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (CRT).
In July, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion, recommending marketing authorization of Imfinzi for the same.
Meanwhile, Imfinzi is also being evaluated as a monotherapy and in combination with chemotherapy, radiation therapy, small molecules, and tremelimumab, an anti-CTLA4 monoclonal antibody, as a first or second-line treatment for patients with NSCLC among other indications.
AstraZeneca currently carries a Zacks Rank #3. It shares have gained 9.4% in the year so far.
Given the stiff competition and market potential, we expect investors to focus on the upcoming PDUFA dates. Regulatory approvals will give companies a significant edge over their existing competitors.
Wall Street’s Next Amazon
Zacks EVP Kevin Matras believes this familiar stock has only just begun its climb to become one of the greatest investments of all time. It’s a once-in-a-generation opportunity to invest in pure genius.
Click for details >>