RepliCel Life Sciences Inc (TSXV:RP)
RepliCel is a regenerative medicine company developing autologous cell therapies that address diseases caused by a deficit of healthy cells required for normal healing and function.
In the field of immuno-oncology, the two dominant players are Merck & Company, with Keytruda and Bristol-Myers Squibb Company with Opdivo. PD-1 and PD-L1 are proteins found on cancer cells that allow them to hide from the immune system. By inhibiting those proteins, the immune system is better able to identify and attack the tumors. PD-1/PD-L1 inhibitors—called checkpoint inhibitors, like Keytruda and Opdivo—are typically paired with a compound or technique that stimulates the immune systems to more actively attack the tumors. And in the market, Keytruda and Opdivo are the two major checkpoint inhibitors.
To date, Bristol-Myers Squibb’s Opdivo has been the bigger seller. But as biopharma companies are reporting their second-quarter financials, for the first time, Merck’s Keytruda beat out Bristol-Myers Squibb’s Opdivo. In the quarter, Keytruda raked in $1.66 billion in sales, which was an 89 percent jump from the second quarter in 2017. Bristol-Myers Squibb reported Opdivo sales of $1.62 billion, an increase of 36 percent for the quarter. According to Credit Suisse, analysts expected Keytruda sales of $1.59 billion.
For comparison, Roche’s Tecentriq, a PD-L1 inhibitor, had sales for the second quarter of 320 million CHF (about $321 million U.S.), an increase of 37 percent.
Opdivo has made some headway recently. In July, the U.S. Food and Drug Administration (FDA) approved Opdivo plus low-dose Yervoy (another of Bristol-Myers Squibb’s checkpoint inhibitors, which attacks CTLA-4 on cancer cells, a different checkpoint protein than PD-1 or PD-L1) for adults and pediatric patients 12 years and older with microsatellite instability high or mismatch repair deficient metastatic colorectal cancer that has progressed after treatment with fluoropyrimidine, oxaliplatin and irinotecan. European regulators have recommended Opdivo for adjuvant treatment of melanoma, in June the FDA accepted its supplemental Biologics License Application (sBLA) for Opdivo and low-dose Yervoy for first-line advanced non-small cell lung cancer (INSCLC), China’s regulators approved Opdivo for locally advanced or metastatic NSCLC after platinum-based chemotherapy, and in May the European Medicines Agency (EMA)validated a type II variation application for Opdivo plus Yervoy for patients with first-line metastatic NSCLC who have a certain amount of a specific mutation.
Yervoy sales, by the way, dropped by 2 percent in the quarter.
Merck’s Keytruda also had quite a bit of activity. The FDA accepted the company’s sBLA for Keytruda as a first-line treatment for metastatic squamous non-small cell lung cancer (NSCLC), regardless of PD-L1 expression. It announced results from its KEYNOTE-042 pivotal Phase III clinical trial evaluating Keytruda as a monotherapy for the first-line treatment of locally advanced or metastatic nonsquamous or squamous NSCLC with PD-L1 tumor proportion score of equal to or more than 1 percent without EGFR or ALK genomic tumor aberrations.
In addition, a cohort from Phase II KEYNOTE-158 trial were promising as a monotherapy in patients with previously treated advanced small cell lung cancer (SCLC). Other trials in other types of cancers and subsets of cancers have also paved the way for approval Keytruda’s use.
Reuters notes, “Keytruda and rival Bristol-Myers Squibb’s Opdivo have piled up approvals for a wide range of cancers. Both the cancer drugs work by triggering the immune system to attack tumors but Merck leads in lung cancer treatments, both alone and in combination with chemotherapy.”
Source: Biospace
