PHESGO: Unique Antibody Combination for Breast Cancer
PHESGO ((PH-Perjeta + Herceptin; ES-Easy; GO- Go) is the world’s first-ever fixed-dose formulation in the history of oncology to combine two monoclonal antibodies (MAbs). The treatment comprises of Herceptin (trastuzumab) and Perjeta (pertuzumab) MAbs with hyaluronidase. It is injected as a single subcutaneous (s.c.) injection into the thigh along with intravenous (i.v.) chemotherapy. This treatment helps in managing early and metastatic breast cancers expressing the human epidermal growth factor receptor 2 (HER2) protein, which is known to promote malignancy.
In June 2020, the US FDA had initially approved PHESGO. Following which, it was approved by the European Medicines Agency (EMA) in December 2020. In India, the Drugs Controller General of India (DGCI) approved PHESGO in October 2021 and the import license was granted in January 2022.
Roche Pharma has stated that more than 17,000 breast cancer patients have benefitted from PHESGO as of December 2021 around the world.
“As per our phase II PHranceSCa study1, 85% of people receiving treatment for HER2-positive breast cancer preferred treatment with PHESGO compared to IV administration due to less time in the clinic and more comfortable treatment administration,” the company stated in its press release.
PHESGO takes only a few minutes in comparison to hours with i.v. formulations for each treatment round. The faster administration decreases the patient chair time by 90%. In addition, it is more cost-effective than purchasing both drugs separately (20% cost reduction) It is a more convenient and less invasive treatment choice for breast cancer patients. Furthermore, it requires less preparation and administration time compared to existing breast cancer therapeutics.
“PHESGO provides the best set of care for HER2-positive breast cancer. It costs 20 percent less than what a patient would have paid if they purchase two products separately. This is a great advantage. PHESGO will also be supported through the blue tree programme. The patients will have holistic benefits and value-added services which come as a part of our blue tree services. We are also working very closely with central government agencies and other insurance segments to make sure that this breakthrough drug is available and accessible to a wider section of patients,” said V Simpson Emmanuel, CEO and Managing Director, Roche Pharma India.
V Simpson Emmanuel, Roche Pharma (India) Chief Executive and Managing Director, said that PHESG0 would reduce the administration time from eight hours to just 20 minutes. Besides increasing patient compliance and convenience, the faster administration would also free up healthcare workers and infrastructure more quickly.
“When the drugs are given through IV, a large quantity of liquid goes into at a very slow speed and takes a lot of time. With PHESGO which is injected directly under the skin, the pressure is higher. The needle is just inserted into the skin and pressed slowly, wait for 5-8 minutes and that’s it. You remove the syringe and the patient is kept under observation for 15 minutes for the follow-up injection and it’s done. With this method, the drug enters the body in a much faster way,” said Bruno Jolain, Chief Medical Director, Roche India.
The side effects of PHESGO therapy mentioned by Roche in their press release include nausea, diarrhea, asthenia (a lack of energy), alopecia (loss of hair), and anemia (low erythrocyte levels). The company stated that PHESGO could worsen chemotherapy-induced neutropenia (low level of leukocytes).
A Roche Pharma representative said, “The safety profile of Phesgo with chemotherapy was comparable to IV administration of Perjeta plus Herceptin and chemotherapy, and no new safety signals were identified, including no meaningful difference in cardiac toxicity.”
In the press release, Emmanuel also mentioned that being imported from Switzerland, PHESGO is currently priced at approximately Rs. 2.75 lakhs; however, with IRDAI (Insurance Regulatory and Development Authority of India) widening insurance coverage to include several modern therapeutic techniques such as immunotherapy, injected MAbs are now being covered by all insurers.
This, in conjunction with assistance from Roche’s Patient Assistance Program, would significantly improve accessibility to the standard of care treatment for breast cancer patients in India. Furthermore, the change of route of administration from intravenous to subcutaneous route could probably move the treatment from oncology wards to daycare and outpatient department (OPD) settings.