The Central Drugs Standard Control Organisation (CDSCO) approval of AstraZeneca’s Imfinzi (durvalumab) in combination with gemcitabine and cisplatin heralds a new era of treatment for biliary tract cancer (BTC) in India, where chemotherapy has been the only choice for over a decade. With no potential competition in near future, the British-Swedish pharma major certainly has a strong competitive edge for BTC treatment in the country, observes GlobalData, a leading data and analytics company.

According to GlobalData’s Pharmaceutical Intelligence Center, the total number of incident cases of bile duct cancer (cholangiocarcinoma) is expected to increase at a compound annual growth rate of approximately 2.2% from 1,993 to 2,473 during 2022 to 2031.

Neha Myneni, Pharma Analyst at GlobalData, comments: “As early-stage BTC often lacks evident symptoms, the disease is usually diagnosed in the advanced stage in about 90% of the cases, when treatment options are limited and the prognosis is poor. Lack of effective treatment options and late diagnosis for such an aggressive form of cancer presents a high unmet clinical need for BTC in India, which could be addressed by AstraZeneca’s new therapy.”

Currently, Imfinzi is the only immunotherapy-based combination treatment option in India that offers significantly improved survival rates in BTC patients. Another potential late-stage pipeline molecule under development for this disease setting is Merck’s Keytruda (pembrolizumab) (Phase III, Global, KEYNOTE-966 trial), which also improved the overall survival when added to standard chemotherapy (gemcitabine/cisplatin), as per the top-line results announced by the company.

However, unlike Imfinzi’s pivotal trial TOPAZ-1, KEYNOTE-966 study does not include Indian population. Hence, the likely approval of Keytruda in India for BTC is skeptical in near future as Indian studies are often preferred for authorisation, giving a competitive edge for AstraZeneca’s drug.

The current approval for Imfinzi is applicable for two dosage strengths: 120 mg/2.4ml and 500mg/10ml solution for infusion. As per GlobalData’s Pharma Intelligence Center, the drug (which is already approved for NSCLC and metastatic urothelial carcinoma in India) is currently priced at approximately $418-$1,741 (INR34,580-INR144,084) for 50mg/2.4ml and 50mg/10ml variants.

The approved dosage strength of Imfinzi for BTC is 1,500mg every three weeks in combination with chemotherapy up to eight cycles, followed by 1,500mg monotherapy every four weeks until disease progression. At this dosage strength and frequency, the annual cost of therapy is expected to be very high and could not be afforded by everyone.

On the diagnosis front, AstraZeneca recently partnered with 4baseCare to develop affordable genomic solutions for advanced-stage cancer patients in India. As approximately 8.6% of all BTCs exhibit high programmed death-ligand 1 expression, biomarker selection and precision treatments are likely to play a key role in optimizing care for this aggressive type of cancer.

Myneni concludes: “However, AstraZeneca should come up with aggressive promotions and affordable pricing strategies for the drug to make it more accessible to those in need. Furthermore, AstraZeneca could leverage its technology partnership with 4base to develop a complementary diagnostic tool for Imfinzi at affordable cost for the early diagnosis of BTC.”